Memantine as a Supplement to Naltrexone in Treating Heroin Dependence (NAMHS)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Opioid Dependence Heroin Dependence |
Drug: Vivitrol Drug: memantine |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Placebo Controlled Study of Memantine as an Adjunct to Naltrexone in the Treatment of Opioid Dependence |
- Opiate use measured by urine toxicology results [ Time Frame: 3x/week during 12 weeks of the trial or study participation ] [ Designated as safety issue: No ]
- Retention in treatment The primary outcome measure will be the dichotomous measure retention in treatment (whether the patient completes the 12 week trial, yes/no). [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
- opiate craving based on Heroin craving scale [ Time Frame: measured daily for 12 weeks of study or length of participation ] [ Designated as safety issue: No ]
| Enrollment: | 82 |
| Study Start Date: | June 2008 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Memantine and Vivitrol
intramuscular injection of Vivitrol 380 mg and 20 mg bid Memantine (PO)
|
Drug: Vivitrol
intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)
Other Name: intramuscular injection of Vivitrol 380 mg
Drug: memantine
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 Name: memantine
|
|
Placebo Comparator: Placebo and Vivitrol
intramuscular injection of Vivitrol 380 mg and Placebo
|
Drug: Vivitrol
intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)
Other Name: intramuscular injection of Vivitrol 380 mg
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult, aged 18-60.
- Meets DSM-IV criteria for current opiate dependence disorder of at least six months duration, supported by a positive urine for opiates and a positive naloxone challenge test if the diagnosis is unclear.
- Able to give informed consent.
Exclusion Criteria:
- Pregnancy, lactation, or failure in a sexually active woman to use adequate contraceptive methods.
- Active medical illness which might make participation hazardous, such as untreated hypertension, acute hepatitis with SGOT or SGPT levels >2 times normal, unstable diabetes, chronic organic mental disorder (e.g., AIDS dementia).
- Active psychiatric disorder which might interfere with participation or make participation hazardous, including DSM-IV schizophrenia, bipolar disorder with mania or psychosis, and depressive disorder with suicide risk or 1 or more suicide attempts within the past year.
- History of allergic reaction to buprenorphine, naloxone, memantine, naltrexone, clonidine, or clonazepam.
- Currently prescribed or regularly taking opiates for chronic pain or medical illness.
- Current participation in another intensive psychotherapy or substance abuse treatment program or currently prescribed psychotropic medications.
- Current participation in a methadone maintenance treatment program and/or regular use of illicit methadone (>30 mg per week).
- History of accidental drug overdose in the last three years or any other significant history of overdose following detoxification defined as an episode of opioid-induced unconsciousness or incapacitation, whether or not medical treatment was sought or received.
Contacts and Locations More Information
No publications provided
| Responsible Party: | New York State Psychiatric Institute |
| ClinicalTrials.gov Identifier: | NCT00476242 History of Changes |
| Obsolete Identifiers: | NCT00126711 |
| Other Study ID Numbers: | #5936R R01 DA015822-01, R01DA015822 |
| Study First Received: | May 17, 2007 |
| Last Updated: | December 13, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by New York State Psychiatric Institute:
|
heroin abuse opiate abuse opioid dependence naltrexone memantine |
Additional relevant MeSH terms:
|
Heroin Dependence Opioid-Related Disorders Substance-Related Disorders Mental Disorders Naltrexone Memantine Narcotic Antagonists Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents |
Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Antiparkinson Agents Anti-Dyskinesia Agents |
ClinicalTrials.gov processed this record on May 16, 2013