Memantine and Naltrexone Treatment for Opioid Dependence

Phase 2

Completed

• Conditions: Opioid Dependence
• Interventions: Drug: Memantine; Drug: Naltrexone

• Registration Number: NCT00125515
• Lead Sponsor: New York State Psychiatric Institute

Brief Summary

The goal of this study is to test the efficacy of memantine (a noncompetitive NMDA receptor antagonist) as an adjunct to the maintenance treatment with naltrexone in detoxified heroin-dependent individuals.

Detailed Description

The primary aim of this study is to test the efficacy of memantine, a noncompetitive NMDA receptor antagonist, in reducing early attrition and improving outcome in opioid-dependent individuals maintained on naltrexone.

This double-blind, 12-week trial will include heroin-dependent patients who completed detoxification. Participants will be randomly assigned to one of three conditions: naltrexone and placebo, naltrexone and memantine (15 mg bid), or naltrexone and memantine (30 mg bid). Naltrexone will be taken 3 times each week at the clinic, while memantine or placebo will be taken at home. In addition, twice each week patients will receive a psychosocial intervention that will include motivational interviewing and cognitive-behavioral relapse prevention. The goal of the psychosocial intervention is to improve compliance with medication and maintain abstinence. Baseline assessments will be taken and compared to those completed at study visits, which will occur 3 times each week.

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-07-28
• Study First Submitted QC: 2005-07-28
• Study First Posted: 2005-08-01
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Results First Submitted: 2012-12-18
• Results First Submitted QC: 2012-12-18
• Results First Posted: 2013-01-24
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-17
• Last Update Posted: 2018-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Memantine 30 mg bid	Naltrexone	Memantine 30 mg bid plus oral naltrexone
Placebo	Naltrexone	Placebo plus oral naltrexone
Memantine 30 mg bid	Memantine	Memantine 30 mg bid plus oral naltrexone
Memantine 15 mg bid	Memantine	memantine 15 mg bid plus oral naltrexone
Memantine 15 mg bid	Naltrexone	memantine 15 mg bid plus oral naltrexone

Primary Outcome Measures

Name	Time	Method
Retention in Treatment	Number of participants who complete 12 weeks of treatment	The number of participants who were retained and completed all 12 weeks of treatment and study participation were compared between the three study groups.

Trial Locations

Locations (1)

New York State Psychiatric Institute; 🇺🇸 New York, New York, United States