The ISAP Outpatient Clinical Research Center
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, cocaine, and methamphetamine dependent individuals. The clinic currently has from 10-15 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
- CTN-0048: Cocaine Use Reduction with Buprenorphine (CURB)
- Sustained-Release Methylphenidate for Management of Methamphetamine Depedence (MPH)
- CTN-0046: Smoking Cessation and Stimulant Treatment (S-CAST)
CTN-0048: Cocaine Use Reduction with Buprenorphine
(CURB)
Synopsis: This study will assess the effectiveness and safety of buprenorphine for the treatment of cocaine dependence. Participants who are cocaine dependence and have a current or past history of opioid misuse, abuse, or dependence are randomly assigned to one of three buprenorphine conditions (4mg Suboxone, 16mg Suboxone, Placebo) in a double-blind design, given in tandem with open-label sustained-release naltrexone (Vivitrol) for an eight-week treatment period with follow-up assessments scheduled for 1-month and 3-months post-treatment. Participants will attend clinic three times weekly for urine testing, assessments, and medication dispensing, and will also receive once weekly individual counseling using a manualized Cognitive Behavioral Therapy format.
Drug Dependence Treated: Cocaine
Contact: Jeff Annon, (310) 267-5333
Sustained-Release Methylphenidate for Management of Methamphetamine Depedence
(MPH)
Synopsis: Compares several treatment approaches including medication and behavioral interventions (group counseling and motivational incentives) for the treatment of methamphetamine dependence. This is a double-blind, placebo-controlled trial in which half of participants are randomly assigned to receive methylphenidate (Concerta®) and half are assigned to receive placebo (sugar pill). Study particpation lasts approxiatimately 4 months, and participants are expected to meet with research personnel 2 days per week throughout the study.
Drug Dependence Treated: Methamphetamine
Contact: Jessica Jenkins, (310) 267-5318
CTN-0046: Smoking Cessation and Stimulant Treatment
(S-CAST)
Synopsis: Evaluates whether concurrent smoking-cessation treatment improves, worsens, or has no effect on stimulant use outcomes in smokers who are currently in outpatient substance abuse treatment for cocaine or methamphetamine dependence at one of the participating sites (Tarzana Treatment Center or Matrix Institute). Participants will be randomly assigned to participate in treatment as typically provided by the program or to receive smoking cessation treatment (including individual smoking-cessation counseling, medication therapy with bupropion and nicotine inhaler, and contingency management) in addition to treatment as usual. Study participation lasts 10 weeks with with follow up visits at 3 and 6 months and participants are expected to meet with research personnel 2 days per week during the study.
Drug Dependence Treated: Methamphetamine, Cocaine
Contact: Tarzana Treatment Center, Nicole Grifka, (818) 996-1051, x1105
Matrix Institute, Dara Yomijinda (909) 989-9724
Last Updated: 10/10/2011