Memantine as a Supplement to Naltrexone in Treating Heroin Dependence
Condition: Opioid Dependence; Heroin Dependence
MeSH terms: Opioid-Related Disorders; Heroin Dependence
Study type: Interventional
Phase: Phase 2/Phase 3

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 description: 
      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.
    

Intervention name(s): Vivitrol; memantine
Intervention type(s): Drug; Drug
Intervention description(s): 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.
Other intervention name(s): intramuscular injection of Vivitrol 380 mg
Intervention MeSH terms: Naltrexone; Memantine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: heroin abuse; opiate abuse; opioid dependence; naltrexone; memantine