NCT00476242|CompletedPhase 2/3Results
Memantine as a Supplement to Naltrexone in Treating Heroin Dependence
NAMHS
Placebo Controlled Study of Memantine as an Adjunct to Naltrexone in the Treatment of Opioid Dependence
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Sponsor study identifier
Secondary identifiers
NIH
interventional
82
1 country
1
Study Start
June 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2011
Actual (reported)Study Completion
August 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 17, 2007
Actual (reported)May 21, 2007
Actual (reported)June 2008
Date type not reportedThis date has not been verified as actual or estimated.
August 2011
Actual (reported)August 2011
Actual (reported)July 4, 2014
Actual (reported)Opiate Use Measured by Urine Toxicology Results
Opiate use was qualified by the number of opiate positive urine results.
3x/week during 12 weeks of the trial or study participation
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).
Week 12
Opiate Craving Based on Heroin Craving Scale
Average of twice weekly assessments for 12 weeks of study or length of participation
intramuscular injection of Vivitrol 380 mg and 20 mg bid Memantine (PO)
intramuscular injection of Vivitrol 380 mg and Placebo
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.
STARS
New York, New York, 10032, United States
Bisaga A, Sullivan MA, Cheng WY, Carpenter KM, Mariani JJ, Levin FR, Raby WN, Nunes EV. A placebo controlled trial of memantine as an adjunct to oral naltrexone for opioid dependence. Drug Alcohol Depend. 2011 Dec 1;119(1-2):e23-9. doi: 10.1016/j.drugalcdep.2011.05.019. Epub 2011 Jun 28.
Adam Bisaga, MD
Columbia University
82 participants (actual enrollment reported by the registry).
First Submitted
May 17, 2007
First Posted
May 21, 2007
Study Start
June 2008
Date type not reportedThis date has not been verified as actual or estimated.
Behavioral Naltrexone Therapy for Promoting Adherence to Oral Naltrexone vs Extended Release Injectable Depot Naltrexone
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
August 2011
Actual (reported)Study Completion
August 2011
Actual (reported)Last Updated
July 17, 2018
Results First Posted
July 4, 2014
Record last verified: 2018-06
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Source: ClinicalTrials.gov.
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