Clinical Trials and Medication Development Projects (2010-2012)


A Phase 2, Double-Blind, Placebo-Controlled Trial of
Bupropion for Methamphetamine Dependence

Walter Ling, M.D., Principal Investigator (lwalter@ucla.edu)
Richard A. Rawson, Ph.D., Site Principal Investigator
Valerie P. Antonini, M.P.H., Project Director

This project was a multi-site double-blind, placebo-controlled, parallel-group design study targeting methamphetamine users, in which participants were randomly assigned to receive either placebo or bupropion daily for 12 weeks. Participants also received group cognitive behavioral therapy (CBT) three times weekly along with weekly assessments to collect information on status and functioning. Additional follow-up assessments occurred weekly for 4 weeks after completion of study interventions.  Eligibility criteria included methamphetamine use on 29 or fewer days (non-daily use) during the 30 days prior to signing consent. The primary goal of this study was to assess the efficacy of bupropion in reducing methamphetamine use in participants using methamphetamine on 29 or fewer days during the 30 days prior to signing consent. It was hypothesized that bupropion, compared to placebo, would be associated with an increase in the proportion of subjects who achieved abstinence (confirmed by at least two methamphetamine-negative urines) each week during the last two weeks (Weeks 11 and 12) for non-daily users. Results are pending final analysis. 

A Phase2, Double-Blind, Placebo-Controlled Trial of Bupropion for Methamphetamine Dependence was funded by the National Institute on Drug Abuse, grant number N01 DA-3-8824, from September 2007 to December 2010.

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Aerobic Exercise to Improve Outcomes of
Treatment for Methamphetamine Dependence

Richard A. Rawson, Ph.D., Principal Investigator (rrawson@mednet.ucla.edu)
Christopher Cooper, MD;  Edythe London, PhD, & Larissa Mooney, MD, Co-Investigators
Joy Chudzynski, Psy.D., Project Director (joychud@ucla.edu)

This 5-year study, funded by NIDA, seeks to assess the efficacy of aerobic and resistance exercise for the treatment of methamphetamine dependence in a population of 150 individuals in residential treatment. After signing consent and satisfying all inclusion requirements, participants undergo baseline assessments during approximately 2 weeks of treatment as usual. After randomization, participants enter either the Education condition, consisting of 45- to 50-minute health education sessions 3 times per week for 8 weeks (n = 75), or the Exercise condition, consisting of aerobic and resistance exercise 3 times per week for 8 weeks (n = 75).

The primary goal of the study is to determine whether inclusion of aerobic and resistance exercise within a residential program improves treatment outcomes in terms of reduced methamphetamine use during the first 12 weeks after discharge and at a 26-week follow-up, as well as to characterize effects of exercise on health, psychiatric symptoms, and cognition compared to the control (education) group at pre/post intervention.

Of the 150 participants, a subset of voluntary participants will take part in a brain imaging substudy. This substudy will use Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI) scans to see if cells in the brain change after therapy and treatment for methamphetamine dependence. Specifically, we will see if group participation (exercise or education group) changes the availability of dopamine in the brain.

Preliminary Data Analysis:

An initial data analysis consisted of 42 individuals who were randomized to 3 days/week of exercise training (EX, n = 22) or health education (ED, n = 21) over an 8-week study period.  Mood was assessed using the Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Profile of Mood States (POMS), and Daily Mood Rating at baseline (BL), weekly, and at intervention completion (Week 8). Neurocognitive function, aerobic fitness, body composition, muscle strength, and endurance were assessed at BL and Week 8.

Results: Both groups showed significant (p < .05) decreases in mean BAI, mean BDI, and mean POMS scores from BL to Week 8. Mean BAI score for EX group (12.1 to 2.2), ED group: (12.0 to 4.4); Mean BDI score for EX: (11.6 to 3.8), ED: (13.7 to 5.8); Mean POMS Total Mood Disturbance for EX: (48.6 to 17.1), ED: (52.5 to 22.8). On a Daily Mood Rating taken after each session, participants in the EX group reported feeling more euphoric (p = .05) and a decrease in craving (p < .05) from BL to Week 8 ,while the ED group did not show any significant changes from BL to Week 8. With regard to neurocognitive measures, performance was improved (p < .05) on memory and motor speed tests for those in the EX group. Regarding physiological measures, participants in the EX group significantly (p < .05) increased oxygen uptake, muscle strength (chest & legs) and endurance (chest & legs), and showed a reduction in body weight, fat weight, and percent relative body fat from BL to Week 8. The ED group did not show any significant changes in the above physiological variables from BL to Week 8.

Conclusions:  Although these results are preliminary, this is the first known study to report the psychological, cognitive and physiological effects of 8 weeks of exercise training on methamphetamine-dependent individuals. The impact of these changes on recovery from methamphetamine dependency remains to be elucidated in this ongoing study.

Aerobic Exercise to Improve Outcomes of Treatment for Methamphetamine Dependence was funded by the National Institute on Drug Abuse, grant 1R01DA027633-01, from  September 2009 to August 2014.

Cell Phone Technology Targeting ART &
Suboxone Adherence and Injection Drug Use

Suzette Glasner-Edwards, Ph.D., Principal Investigator (sglasner@ucla.edu)
Richard Rawson, Ph.D., Walter Ling, M.D., Alison Hamilton, Ph.D.,
Larissa Mooney, M.D., & Michele Ybarra, Ph.D., Co-Investigators
Helene Chokron Garneau, M.P.H., Project Director

The objective of the current research is to improve treatment for injection opioid users by augmenting buprenorphine pharmacotherapy with an innovative text-messaging strategy to promote relapse prevention skills, reduce HIV-risk behaviors, and improve buprenorphine and HIV treatment regimen adherence. The specific aims of this research are (1) To develop and refine, with user feedback, a cognitive behavioral therapy-based text-messaging intervention (TXT-CBT) to augment buprenorphine pharmacotherapy in HIV-infected injection drug users (IDUs) with opioid dependence; (2) To conduct a pilot randomized clinical trial to assess the feasibility of recruiting and retaining individuals for a large-scale study and to determine the effect size of TXT-CBT over and above medication management with buprenorphine (MM) on opioid use, HIV medication adherence, buprenorphine adherence, and healthcare outcomes; and (3) To examine potential mechanisms of action of TXT-CBT, including self-efficacy, affect regulation, and social support. We hypothesize that TXT-CBT delivered in conjunction with MM will produce greater reductions in opioid use and HIV-risk behaviors, and will improve buprenorphine and HIV treatment regimen adherence, relative to MM alone. Further, we expect that MM+TXT-CBT will facilitate greater changes in negative affect, self-efficacy, and social support, and these changes will be associated with substance use outcomes. By providing support to maximize HIV treatment regimen adherence, coupled with coping skills to address withdrawal symptoms and stress, two important factors in opioid relapse, TXT-CBT may provide a promising, cost-effective, and easily deployable augmenting strategy for the treatment of opioid users who are HIV-infected.

Cell Phone Technology Targeting ART & Suboxone Adherence and Injection Drug Use was funded by the National Institute on Drug Abuse, grant 1 R34 DA0133196, from July 2012 to June 2015.

Duloxetine for Depressed Substance Abusers

Suzette Glasner-Edwards, Ph.D., Principal Investigator (sglasner@ucla.edu)
Richard A Rawson, Ph.D., and Walter Ling, M.D., Co-Investigators

This pilot study examined the efficacy of duloxetine combined with group psychotherapy for individuals with stimulant dependence and comorbid major depressive disorder. Although the past decade has seen new pharmacological and psychological interventions producing improvement in substance use outcomes, few studies have systematically explored the efficacy of these approaches in combination with patients with substance use disorders and comorbid mental health disorders. This open-label trial included 20 dually diagnosed individuals with stimulant dependence and Major Depressive Disorder. We examined the efficacy of 12 weeks of treatment with duloxetine and group psychotherapy on outcomes for depression and substance use. The primary hypothesis was that duloxetine in conjunction with psychotherapy would produce reductions in depressive symptoms and stimulant use. Results: Duloxetine was found to be safe and efficacious in a population of stimulant-dependent adults with concomitant major depressive disorder. Among those who completed the study, a significant reduction (greater than 50%) in depressive symptom severity from baseline was observed at treatment-end, as measured by both clinician-rated (HAM-D) and participant self-report (BDI) measures.  Hypotheses concerning secondary outcomes were partially met. Minimal improvement in stimulant use and global improvement in stimulant dependency was observed over the course of the trial. Nevertheless, consistent with hypotheses, there was a significant reduction in pain severity reported by participants from baseline to the end of treatment. The results of this open-label pilot trial indicate that among stimulant-dependent adults with comorbid depressive illness, duloxetine is a safe and efficacious medication for the treatment of depression and to target associated pain symptomatology. However, effects of this treatment on substance use appear to be minimal.

Duloxetine For Depressed Substance Abusers was funded by the Eli Lilly Corporate Center, contract number F1J-US-X046, from October 2007 to May 2011.

Mindfulness-Based Relapse Prevention for Stimulant Users

Suzette Glasner-Edwards, Ph.D., Principal Investigator (sglasner@ucla.edu)
Richard Rawson, Ph.D., Larissa Mooney, M.D., Co-Investigators

The objective of this research was to improve treatment for stimulant dependence by augmenting traditional relapse prevention therapy with innovative meditation-based strategies to promote affect regulation skills. Based on Mindfulness-Based Cognitive Therapy for depression (Segal, Teasdale, & Williams, 2002), Marlatt and colleagues recently developed a manualized intervention for the treatment of substance-using populations: Mindfulness Based Relapse Prevention (MBRP). The specific aims of this research were (1) to conduct a pilot randomized clinical trial comparing MBRP relative to a health education (ED) control group in stimulant users receiving contingency management (CM); (2) to test the impact of MBRP compared to ED on negative affect, stimulant use, and healthcare outcomes; and (3) to examine potential mechanisms of action of MBRP, including reductions in stress reactivity and biological indicators of arousal (e.g., blood pressure and heart rate).  Results: Medium effect sizes favoring the MBRP condition were observed for affect regulation and overall psychiatric severity outcomes. Specifically, depressive symptom severity, measured by the Beck Depression Inventory, changed differentially and significantly over time as a function of intervention condition, with MBRP participants reporting greater reductions that were sustained through 1 month posttreatment (p < 0.03; Effect Size = 0.58). Likewise, the MBRP group evidenced greater declines over time in anxiety symptoms, measured by the Beck Anxiety Inventory (p < 0.02; Effect Size = 0.72 at 1 month posttreatment) and psychiatric severity, indicated by the Addiction Severity Index (p < 0.02; Effect Size = 0.61). Results of a laboratory test of stress reactivity, the Trier Social Stress Task, indicated that cortisol levels were elevated across multiple measurements in the hour following exposure to a stressor in a substantially larger proportion of control group participants, relative to MBRP participants, for whom post-stressor cortisol levels returned to baseline or lower. Problems associated with stimulant addiction declined to a greater extent through 1 month posttreatment among those in MBRP, an effect that approached significance (p = 0.06). Analyses of stimulant use outcomes in association with changes in negative affect and stress reactivity and intervention condition are presently under way. Taken together, the present findings strongly suggest that Mindfulness Based Relapse Prevention has great utility as an adjunct to behavioral interventions targeting stimulant use (i.e., contingency management) in that it effectively reduces negative affect, stress reactivity, and psychiatric impairment, and may reduce dependency severity among stimulant users.

Related Presentation:
Glasner-Edwards, S., Mooney, M, Brecht, L., & Rawson, R. (2012). Mindfulness-based relapse prevention reduces negative affect and stress reactivity among stimulant-dependent adults. Poster presentation at the 74th Annual Meeting of The College on Problems of Drug Dependence Palm Springs, CA, June 9-14.

Mindfulness-Based Relapse Prevention for Stimulant Users was funded by the National Institute on Drug Abuse, grant 1 R21 DA029255, from April 2010 to March 2012.

Motivational Therapy for Substance Users with Depression

Suzette Glasner-Edwards, Ph.D., Principal Investigator (sglasner@ucla.edu)
Anne Bellows, Project Director

This study examined the incremental efficacy of an aftercare  psychosocial treatment program of a motivational intervention combined with cognitive behavioral therapy (CBT), relative to standard care or treatment as usual (TAU) for individuals with alcohol or drug dependence and comorbid major depressive disorder. Although the past decade has seen new cognitive and motivational interventions producing improvement in substance use outcomes, few studies have systematically explored the efficacy of these approaches in combination in patients with substance use disorders and comorbid mental health disorders. This randomized psychosocial clinical trial included 70 dually diagnosed individuals with alcohol or drug dependence and a substance-independent diagnosis of Major Depressive Disorder. Among patients receiving pharmacotherapy for depression, we compared 12 weeks of CBT combined with motivational therapy (CBT-MT) to 12 weeks of treatment-as-usual (TAU) on 6-, 12-, and 24-week outcomes for depression, substance use, and other healthcare outcomes. Preliminary findings suggest that participation in CBT-MT was associated with better treatment engagement and retention, relative to TAU. In turn, greater engagement and compliance with treatment was associated with larger improvements in depressive symptomatology. Analyses of substance use outcomes will also be conducted. The results of this study might provide a dual-diagnosis specific, cognitive-motivational alternative to traditional aftercare programs for the treatment of stimulant users with depression.   

Related Presentation:
Glasner-Edwards, S., Brown, S.A., & Rawson, R.A. (November, 2012). Integrated CBT and motivational enhancement therapy versus community 12-step participation as continuing care for substance dependent adults with major depression: preliminary results of a pilot clinical trial. Paper presented at the 46th Annual Meeting of the Association of Behavioral and Cognitive Therapy, National Harbor, Maryland.

Motivational Therapy for Stimulant Users with Depression was funded by the National Institute on Drug Abuse, Grant 1 K23 DA020085 (September 2007 to August 2012).

Optimizing Outcomes Using Suboxone for Opiate Dependence

Walter Ling, M.D., Principal Investigator (lwalter@ucla.edu)
Maureen Hillhouse, Ph.D, & Richard Rawson, Ph.D., Co-Investigators

This study was a randomized controlled trial that tested the comparative efficacy of several approaches combining psychosocial treatment with pharmacotherapy for treatment of opioid dependence. In conjunction with buprenorphine pharmacotherapy, psychosocial treatment conditions  included a cognitive behavioral therapy (CBT) condition with medical management (MM), a Contingency Management condition (CM) with MM, a combined CBT+CM condition with MM, and a standard MM condition with neither CBT nor CM, which approximated what physicians do in general when prescribing buprenorphine in their office practice to patients with opioid dependence. Eligible participants were stabilized on the study drug for a period of 2 weeks and then were randomly assigned to one of the four conditions for 16 weeks. This first period was followed by a second 16-week period during which all participants continued to receive buprenorphine treatment but did not engage in any psychosocial treatment as part of continued study participation. Medical management of the participants was identical to that delivered during the first treatment phase. At the end of this second 16-week buprenorphine-only treatment period, participants were tapered off buprenorphine within a maximum of 6 weeks, or received referral for continued treatment if they were unable to successfully complete the taper. Participants were again assessed at 40-weeks and 52-weeks post-entry into the study. Participants were 202 opioid-dependent males and non-pregnant, non-lactating females of all racial/ethnic groups who were at least 15 years of age.

Optimizing Outcomes Using Suboxone for Opiate Dependence was funded by the National Institute on Drug Abuse, grant 1 R01 DA020210, from September 2006 to May 2011.

Optimizing Outcomes Using Suboxone for Opiate Dependence
Walter Ling, M.D., Principal Investigator (lwalter@ucla.edu)
Maureen Hillhouse, Ph.D, & Richard Rawson, Ph.D., Co-Investigators
Jackie Fahey, M.S., Project Director

This study is a randomized controlled trial that will test the comparative efficacy of several approaches combining psychosocial treatment with pharmacotherapy for treatment of opioid dependence. In conjunction with buprenorphine pharmacotherapy, psychosocial treatment conditions will include a Cognitive Behavioral Therapy (CBT) condition with medical management (MM), a Contingency Management condition (CM) with MM, a combined CBT+CM condition with MM, and a standard MM condition with neither CBT nor CM, which approximates what physicians do in general when prescribing buprenorphine in their office practice to patients with opioid dependence. Eligible participants will be stabilized on the study drug for a period of 2 weeks and will then be randomly assigned to one of the four conditions for 16 weeks. This first period will be followed by a second 16-week period during which all participants will continue to receive buprenorphine treatment but will not engage in any psychosocial treatment as part of continued study participation. Medical management of the participants will be identical to that delivered during the first treatment phase. At the end of this second 16-week buprenorphine-only treatment period, participants will be tapered off buprenorphine within a maximum of 6 weeks, or will receive referral for continued treatment if unable to successfully complete the taper. Participants will again be assessed at 40-weeks and 52-weeks post-entry into the study. Participants will be 240 opioid-dependent males and non-pregnant, non-lactating females of all racial/ethnic groups who are at least 15 years of age.

Optimizing Outcomes Using Suboxone for Opiate Dependence was funded by the National Institute on Drug Abuse, Grant 1 R01 DA020210 (September 2006 to May 2011).


PRO 806: A Randomized, Placebo and Active-Controlled,
Multi-Center Study of Probuphine in
Patients with Opioid Dependence

Walter Ling, M.D., Principal Investigator (lwalter@ucla.edu)

This study was a randomized, placebo- and active-controlled, multi-center study to assess the effectiveness of Probuphine (buprenorphine hydrochloride/ethylene vinyl acetate), an implantable formulation of buprenorphine hydrochloride (HCl) under development for the treatment of opioid dependence. Probuphine was inserted subdermally into the inner side of the subject's upper arm, in a brief in-office procedure under local anesthetic, and was designed to provide sustained release of BPN for 6 months.  Each Probuphine implant consisted of 80 mg of BPN HCl that had been blended and extruded with ethylene vinyl acetate (EVA). Each placebo implant consisted of extruded ethylene vinyl acetate (EVA).  Both the Probuphine and placebo implants were sterile and measured approximately 26 mm in length and 2.5 mm in diameter. Across all sites, approximately 250 subjects from 20–25 clinical centers who met eligibility criteria were randomized to 1 of 3 treatment groups in a 2:1:2 ratio [Group A: 4 Probuphine implants (n=100); Group B: 4 placebo implants (n=50); Group C: 12–16 mg/day SL BPN (n=100)], for 24 weeks of treatment. 

PRO 806: A Randomized, Placebo and Active-Controlled, Multi-Center Study of Probuphine in Patients with Opioid Dependence was funded by Titan Pharmaceuticals, Inc., contract 20080840, from April 2010 to March 2011.

PRO-811: A Phase 3, Six-Month, Open-Label
Re-Treatment Study of Probuphine in Opioid Addiction

Walter Ling, M.D., Principal Investigator (lwalter@ucla.edu)
Larissa Mooney, M.D., Co-Investigator (lmooney@mednet.ucla.edu)
Jessica Jenkins, M.A., Project Director

The primary objective of this trial was to evaluate the safety of Probuphine in subjects who have completed 24 weeks of treatment and who were re-treated with Probuphine for an additional 24 weeks. Probuphine (buprenorphine hydrochloride/ethylene vinyl acetate) is an implantable formulation of buprenorphine hydrochloride (HCl) under development for the treatment of opioid dependence following induction with sublingual buprenorphine (BPN). Probuphine was inserted subdermally into the inner side of the subject's upper arm, in a brief in-office procedure under local anesthetic. It may also have been inserted in an alternate location if deemed medically necessary by the implanting clinician. Probuphine is designed to provide sustained release of BPN for 6 months. At the end of each 6-month treatment, Probuphine was removed in a brief, in-office procedure under local anesthetic. Each Probuphine implant consisted of 80 mg of BPN HCl that had been blended and extruded with ethylene vinyl acetate (EVA). Each placebo implant consisted of extruded ethylene vinyl acetate (EVA). Both the Probuphine and placebo implants were sterile and measured approximately 26 mm in length and 2.5 mm in diameter. Subjects who completed study PRO-806 (see above) were eligible to be enrolled in PRO-811. This study provided safety data in subjects treated with Probuphine for up to 2 consecutive 6-month treatment periods. For more information, please visit http://www.titanpharm.com/products.htm.

PRO-811: A Phase 3, Six-Month, Open-Label Re-Treatment Study of Probuphine in Opioid Addiction was funded by Titan Pharmaceuticals, Inc., contract PRO-811, from January 2011 to January 2012.

Sustained-Release Methylphenidate for Management of
Methamphetamine Use Disorders

Walter Ling, M.D., Principal Investigator (lwalter@ucla.edu)
Maureen Hillhouse, Ph.D., & Richard Rawson, Ph.D., Co-Investigators
Jessica Jenkins, M.S., Project Director

This study will evaluate the ability of sustained-release methylphenidate (MPH) to reduce stimulant abuse and increase treatment retention among 90 individuals seeking treatment for methamphetamine dependence. The4-year double-blind, placebo-controlled study includes methamphetamine-dependent individuals assessed using DSM-IV criteria. Eligible participants are randomized to placebo (n = 45) or MPH (n = 45) for 10 weeks in the double-blind phase. Active medication participants receive 18mg MPH/daily for Week 3, 36mg/daily for Week 4, and 54mg/daily for Weeks 5-10. Placebo participants are given a placebo that is prepared to appear identical to active medication. During the active medication phase, all participants are also provided with weekly group sessions of cognitive behavioral therapy (CBT), and motivational incentives (MI) are provided for methamphetamine-negative urine test results. After the active medication phase, all participants receive placebo for the final 4 study weeks (Weeks 11-14) in the single-blind phase, and continue CBT and MI. 

Sustained-Release Methylphenidate for Management of Methamphetamine Use Disorders was funded by the National Institute on Drug Abuse, grant 1 R01 DA025084, from February 2009 to December 2012.

The National Drug Abuse Clinical Trials Network

Walter Ling, M.D., Principal Investigator (lwalter@ucla.edu)
Richard A. Rawson, Ph.D., Larissa Mooney, M.D., & Steven Shoptaw, Ph.D., Co-Investigators
Albert L. Hasson, M.S.W., Project Director

As one of 13 Regional Research Training Centers, ISAP has completed its 12th year as the Pacific Region Node of NIDA’s Clinical Trials Network (CTN), and continues to collaborate with academic centers and local community treatment programs in an effort to make substance abuse research more relevant to the treatment community.  The Pacific Region Node is pleased to have recently teamed up with Dr. Linda Chang at the University of Hawaii, Queens Medical Center, to work cooperatively to develop and implement CTN protocols to address methamphetamine abuse and dependence.  Dr. Chang is one of the world’s foremost researchers on brain imaging and the impact of substance abuse on brain function.  ISAP continues its longstanding relationship with community treatment programs: The Betty Ford Center, Bay Area Addiction Research and Treatment, Inc., Matrix Institute on Addictions, Hina Mauka Treatment Programs, Tarzana Treatment Center, and  most recently, the Harbor-UCLA Division of HIV Medicine through the implementation of the CTN 0049 study, Hospital Visit as Opportunity for Prevention and Engagement for HIV-Infected Drug Users (HOPE).

In November 2012, CTN 0048, Cocaine Use Reduction with Buprenorphine, CURB, led by Drs. Ling, Saxon, and Mooney completed recruitment and is in the final stages of data collection at 10 sites nationwide.  Concerns over the recruitment and implementation of this relatively complex trial were unfounded as the 10 sites, including the ISAP Outpatient Clinical Research Center completed recruitment 7 months in advance of the projected recruitment timeline.  The CURB “methods” paper has been accepted by the journal Contemporary Clinical Trials

Following the completion of the 9-site trial comparing the impact of Suboxone and methadone on liver function in treatment-seeking opioid-dependent individuals, Starting Treatment with Agonist Replacement Therapies (START), Maureen Hillhouse, Ph.D., led several working groups in the development and publication of the study results.  The START main outcome results were published in the August 2012 Journal of Drug Alcohol Dependence, with several more manuscripts in the development phase.   

The Pacific Region Node community treatment programs continue to play an active role in the NIDA CTN. Under the direction of Marie Hughes and Monique Weisman, staff at the Hina Mauka, Waipahu facility, made their Hawaii site the nation’s top recruitment location for CTN 0044, Web-delivery of Evidence-Based, Psychosocial Treatment for Substance Use Disorders, an evaluation of the addition of a Web-based intervention to face-to-face counseling and are participating in the development of project manuscripts.  The Matrix Institute on Addictions, Rancho Cucamonga, and the Tarzana Treatment Center completed recruitment and data collection on CTN 0046, Smoking Cessation and Stimulant Treatment (S-CAST): Evaluation of the Impact of Concurrent Outpatient Smoking-Cessation and Stimulant Treatment on Stimulant-Dependent Outcomes.  Currently in development at UCLA ISAP for the NIDA CTN is the CTN 0054 protocol, Accelerated Development of Additive Pharmacotherapy Treatment for Methamphetamine Dependence (ADAPT-MD).  ADAPT-MD is a three-site, two-stage trial designed to investigate a combination medication, extended-release depot naltrexone plus extended release bupropion as a potential pharmacotherapy for methamphetamine dependence.  ADAPT will be led by Drs. Walter Ling and Larissa Mooney of the Pacific Region Node.  Recruitment for this project is scheduled to begin in the spring of 2013.   (Additional information is available at www.uclaisap.org/ctn/index.html.)

The National Drug Abuse Clinical Trials Network was funded by the National Institute on Drug Abuse, grant 2 U10 DA13045, from  September 2005 through August 2010.
Last Updated:  12/04/2012

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