2005 - Memantine in Treating Heroin-Dependent Individuals - 1
Effectiveness of Memantine in Treating Heroin-Dependent Individuals - 1
This study is currently recruiting patients.
Verified by National Institute on Drug Abuse (NIDA) August 2005
Sponsors and Collaborators: National Institute on Drug Abuse (NIDA)
New York State Psychiatric Institute
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00126711
Purpose
Currently, naltrexone is one of the methods used to treat heroin dependence. However, treatment with naltrexone has been controversial due to poor compliance. The purpose of this study is to evaluate the effectiveness of memantine as a supplement to naltrexone in treating heroin-dependent individuals.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Memantine as a Supplement to Naltrexone in Treating Heroin Dependence
Further Study Details:
Primary Outcomes: Safety; Heroin abstinence
Expected Total Enrollment: 200
Study start: June 2005
Maintenance treatment with opioid agonists is the major pharmacological strategy that is currently available for the treatment of heroin dependence. However, this treatment approach remains controversial and has several limitations. Another pharmacological strategy, naltrexone maintenance, has limited usefulness due to poor compliance and low acceptability in patients seeking treatment. Therefore, alternative treatment approaches, including novel medications as well as pharmacological and behavioral augmentation strategies, are greatly needed to supplement naltrexone maintenance. The purpose of this study is to evaluate the efficacy of memantine as an adjunct to standard naltrexone treatment in heroin-dependent individuals.
This double-blind, 12-week trial will include 200 heroin-dependent individuals who have completed detoxification. Participants will be randomly assigned 1 of 3 conditions: naltrexone and placebo, naltrexone and memantine (15 mg bid), or naltrexone and memantine (30 mg bid).
Memantine and matching placebo will be prepared and dispensed by the research pharmacy in New York State Psychiatric Institute. Compliance with memantine will be assessed monthly based on blood samples for serum memantine levels. Memantine or placebo will be taken at home, whereas naltrexone will be taken 3 times each week at the clinic. Naltrexone doses of 100 mg will be given on Mondays and Wednesdays, and doses of 150 mg will be given on Fridays. Study visits for all participants will occur 3 times each week during the 12-week trial. These visits will include urine toxicology tests, bloodwork, and research ratings (including safety measures and side effect assessments). In addition, twice each week participants will receive a psychosocial intervention that will include motivational interviewing and cognitive-behavioral relapse prevention. Participants will be re-evaluated at 1, 2, and 3 months following Week 12 of treatment.
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