Clinical Trial: Memantine as a Supplement to Naltrexone in Treating Heroin Dependence
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Placebo Controlled Study of Memantine as an Adjunct to Naltrexone in the Treatment of Opioid Dependence
Brief Summary: Prospective participants will undergo a screening process at the clinic to determine eligibility. After screening, eligible patients will complete an 8-day inpatient detoxification, followed by a 12-week outpatient phase. Patients will be randomly assigned to one of two conditions (1) Naltrexone + Placebo; (2) Naltrexone + Memantine 20 mg bid. Long-acting, injectable form of naltrexone (Vivitrol) will be administered once per month (the total of three injections) while memantine or placebo will be taken daily. In addition, patients will receive twice weekly psychosocial intervention that will include motivational interviewing and cognitive-behavioral relapse prevention. The outpatient treatment will also consist of 3 weekly visits to the clinic in which patients will receive counseling to help maintain abstinence and improve compliance with study medication.
Detailed Summary: In the proposed trial heroin-dependent patients undergoing detoxification will be randomly assigned to one of two conditions (1) Naltrexone + Placebo; (2) Naltrexone + Memantine 20 mg bid. Long-acting, injectable form of naltrexone (Vivitrol) will be administered once per month (the total of three injections) while memantine or placebo will be taken daily. In addition, patients will receive twice weekly psychosocial intervention that will include motivational interviewing and cognitive-behavioral relapse prevention. The goal of psychosocial intervention is to improve compliance with medication and maintain abstinence. A double-blind trial will last twelve weeks with assessments at baseline and at each appointment three times per week. After the completion of a double-blind study (experimental phase), participants will continue open label treatment with Vivitrol and therapy for additional three months (study extension phase). Repeated assessments will also be completed one, two, and three months following the end of double-blind treatment. For the experimental phase of the study, the primary aim is to test the efficacy of memantine in reducing early attrition and improving outcome in opioid-dependent individuals maintained on naltrexone and primary outcome measures will be retention in treatment by the end of the study and heroin abstinence.
Sponsor: New York State Psychiatric Institute
Current Primary Outcome:
- Opiate Use Measured by Urine Toxicology Results [ Time Frame: 3x/week during 12 weeks of the trial or study participation ]Opiate use was qualified by the number of opiate positive urine results.
- Retention in Treatment The Primary Outcome Measure Will be the Dichotomous Measure Retention in Treatment (Whether the Patient Completes the 12 Week Trial, Yes/no). [ Time Frame: Week 12 ]
Original Primary Outcome: urine toxicology results
Current Secondary Outcome: Opiate Craving Based on Heroin Craving Scale [ Time Frame: measured daily for 12 weeks of study or length of participation ]
Original Secondary Outcome: self reported opiate use
Information By: New York State Psychiatric Institute
Dates:
Date Received: May 17, 2007
Date Started: June 2008
Date Completion:
Last Updated: June 4, 2014
Last Verified: April 2014
