The ISAP Outpatient Clinical Research Center
Outpatient
Clinical Research Center Projects
The ISAP Outpatient Clinical Research Center conducts a range of substance abuse treatment research activities primarily involving Phase I, II, and III clinical trials. Launched in 2006, the center began recruitment for a single protocol under the umbrella of NIDA’s Clinical Trials Network (CTN), but the number of projects the center conducts has since increased and they now include pharmaceutical company sponsored trials and research funded through competitive NIH grants.
The populations served by this clinic include opioid and methamphetamine dependent individuals. The clinic currently has from 5-15 participants being assessed/treated each day across all protocols, but the mechanisms are in place to increase that number to approximately 50 per day.
The clinical research team, which has extensive clinical and research experience, continues to strive to achieve broad and ambitious research goals. Clinic staffing includes: (1) a medical team (physicians and nurses) that delivers medical assessments and related treatments and is responsible for the medical research and care of study participants; (2) experienced senior researchers with either medical degrees or doctorate degrees, who are responsible for study design and implementation, the safe execution of the protocol, and the integrity of study data; (3) a master’s level clinical team that delivers psychosocial interventions; (4) regulatory affairs monitors; (5) a quality assurance team; and (6) a group of highly trained and experienced research coordinators, project directors, and research associates.
For research information please call 310-267-5020.
Outpatient Clinical Research Center Projects
- Prescription Opiate Addiction Treatment (POAT)
- A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Probuphine in Patients with Opioid Dependence (Titan)
- Optimizing Outcomes Using Suboxone® for Opiate Dependence (Optimizing Bup)
- Starting Treatment with Agonist Replacement Therapies (START)
- Double-Blind, Placebo-Controlled Trial of Prometa™ Pharmacotherapy for the Treatment of Methamphetamine Abuse (Prometa)
Prescription
Opiate Addiction Treatment
(POAT)
Synopsis: Examines the effectiveness of combining Suboxone (buprenorphine) pharmacotherapy with one of two treatment programs for prescription opioid dependence: (1) General doctor's appointments, or (2) General doctor's appointments AND individualized drug counseling sessions. Participants are expected to meet up to 2 days per week with the study physician, study staff, and/or counselor. Study participation lasts up to 36 weeks.
Drug Dependence Treated: Prescription Opioids
Contact: (ISAP) Vanessa DeGuzman, (310) 267-5238
A
Randomized, Double-Blind, Placebo-Controlled, Multi-Center
Study
of Probuphine in Patients with Opioid Dependence
(Titan)
Synopsis: Assesses the efficacy of an implantable form of buprenorphine (Probuphine) for the treatment of opioid dependence. Participants have a 2 out of 3 chance of receiving the implant with medication; the other third receive the placebo. Participants attend counseling and meet with a physician weekly. Study participation lasts approximately 7 months. This study has been enrolling since April 2007 and continues to enroll.
Drug Dependence Treated: Opioids
Contact: Catherine Domier, (310) 267-5324
Optimizing Outcomes Using Suboxone® for Opiate Dependence (Optimizing Bup)
Synopsis: Compares several approaches of combining psychosocial treatment with Suboxone (buprenorphine) pharmacotherapy for the treatment of opioid dependence. Study participation lasts approximately 10 months with a follow-up visit at 1 year. Participants are expected to meet with research personnel up to 2 days per week during the study. The study is anticipated to start July, 2007.
Drug Dependence Treated: Opioids
Contact: Jackie Fahey, (310) 267-5304
Starting
Treatment with Agonist Replacement Therapies
(START)
Synopsis: Assesses changes in liver enzymes related to treatment with either Suboxone (buprenorphine) or methadone. Study participation lasts approximately 8 months with a follow-up contact 30 days later. This study has been enrolling since 2006 and continues to enroll. Study site is located approximately 5 miles south of UCLA ISAP.
Drug Dependence Treated: Opioids
Contact: Dan George, (323) 933-9186
Double-Blind,
Placebo-Controlled Trial of Prometa™ Pharmacotherapy
for the Treatment of Methamphetamine Abuse
(Prometa)
Synopsis: Efficacy of the PROMETA protocol (a treatment for methamphetamine dependent individuals) will be examined in a double blind placebo controlled study. Study participants and the research team will not know which medication group a study participant is in. To be considered for this study, a person must be18 years or older, live in the Los Angeles area or Hawaii, and commit 16 weeks of participation to the study. The study began enrolling participants in May 2006 (Santa Monica and Panorama City) and will open two new sites (Los Angeles and Hawaii) by the end of 2007 summer.
Drug Dependence Treated: Methamphetamines
Contact: Mark Oyama, (310) 267-5326
Last Updated: 07/05/2007