NCT00125515

Memantine and Naltrexone Treatment for Opioid Dependence

Evaluation of NMDA Antagonist for Opiate Dependence

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Opioid Dependence

Interventions

Type	Name	Description
DRUG	Memantine	One arm receives 30 mg bid and the other arm receives receives 15mg bid
DRUG	Naltrexone	Patients received the equivalent of 50 mg/day. Dispensed as 100 mg on Mondays and Wednesdays and 150 mg on Fridays.

Timeline

• Start date: 2005-06-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2005-08-01
• Last updated: 2018-06-18
• Results posted: 2013-01-24

Locations

1 site across 1 country: United States