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
- Optimizing Outcomes Using Suboxone® for Opiate Dependence (Optimizing Bup)
- Starting Treatment with Agonist Replacement Therapies (START)
- A Randomized, Double-Blind, Cross-Over Trial Comparing the Analgesic Potency and Side Effects of Buprenorphine + Ultra-Low-Dose Naloxone to Buprenorphine Alone (LDN)
- Duloxetine for Depressed Stimulant Users
Optimizing Outcomes Using Suboxone® for Opiate Dependence (Optimizing
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
A Randomized, Double-Blind, Cross-Over Trial Comparing the Analgesic Potency and Side Effects of Buprenorphine + Ultra-Low-Dose Naloxone to Buprenorphine Alone (LDN)
Synopsis: The study’s primary objective is to determine whether treatment with IV Buprenorphine in combination with ultra-low-dose naloxone results in increased analgesic potency, fewer side effects, and reduced opioid tolerance compared to treatment with IV Buprenorphine alone. The study will use a randomized double-blind, crossover design in which eligible participants will undergo treatment with one of the study drugs for five days followed by treatment with the alternate medication for five days. A total of 12 participants with chronic non-cancer pain requiring opioid and/or nonopioid analgesics for pain control (of moderate to moderately severe pain) who meet all study inclusion and no study exclusion will be enrolled in the study.
Medical Problem Addressed: Moderate to moderately severe pain
Contact: Jessica Jenkins, (310) 267-5318
Duloxetine for Depressed Stimulant Users
Synopsis: Examines the effectiveness of Cymbalta (duloxetine) pharmacotherapy in conjunction with group psychotherapy for stimulant dependence. Participants are expected to meet one day per week with the study physician, study staff, and/or counselor. Study participation lasts up to 16 weeks.
Drug Dependence Treated: Stimulants
Contact: Mark Oyama, (310) 267-5326
Last Updated: 10/07/2009