At a glance
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Placebo Controlled Study of Memantine as an Adjunct to Naltrexone in the Treatment of Opioid Dependence
In Brief
A Phase 3 clinical trial evaluating Vivitrol and memantine for Opioid Dependence and Heroin Dependence. Completed, enrolled 82 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)
Memantine will be given in two divided doses, starting with the second day of the naltrexone induction, with the target doses of 40 mg/day (or the maximum tolerated dose), for a total of twelve weeks of medication treatment.