Trial Outcomes & Findings for Memantine as a Supplement to Naltrexone in Treating Heroin Dependence (NCT NCT00476242)

NCT ID: NCT00476242

Last Updated: 2018-07-17

Results Overview

Opiate use was qualified by the number of opiate positive urine results.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 82 participants
• Primary outcome timeframe: 3x/week during 12 weeks of the trial or study participation
• Results posted on: 2018-07-17

Participant Flow

27 participants dropped during the inpatient detoxification, therefore only 55 participants were randomized out of the 82 total enrolled.

Participant milestones

Measure	Placebo and Vivitrol Participants treated with placebo capsules and Vivitrol.	Memantine and Vivitrol Participants treated with memantine 40 mg/d capsules and Vivitrol.
Overall Study STARTED	27	28
Overall Study COMPLETED	19	12
Overall Study NOT COMPLETED	8	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Memantine as a Supplement to Naltrexone in Treating Heroin Dependence

Baseline characteristics by cohort

Measure	Memantine and Vivitrol n=28 Participants intramuscular injection of Vivitrol 380 mg and 20 mg bid Memantine (PO) Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections) 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.	Placebo and Vivitrol n=27 Participants intramuscular injection of Vivitrol 380 mg and Placebo Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)	Total n=55 Participants Total of all reporting groups
Age, Continuous	39.7 years STANDARD_DEVIATION 12.0 • n=5 Participants	39.0 years STANDARD_DEVIATION 11.5 • n=7 Participants	39.4 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	20 Participants n=7 Participants	44 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants	27 participants n=7 Participants	55 participants n=5 Participants

PRIMARY outcome

Timeframe: 3x/week during 12 weeks of the trial or study participation

Opiate use was qualified by the number of opiate positive urine results.

Outcome measures

Measure	Memantine and Vivitrol n=28 Participants intramuscular injection of Vivitrol 380 mg and 20 mg bid Memantine (PO) Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections) 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.	Placebo and Vivitrol n=27 Participants intramuscular injection of Vivitrol 380 mg and Placebo Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)
Opiate Use Measured by Urine Toxicology Results	9 Percent of total urine samples Interval 3.0 to 40.0	10 Percent of total urine samples Interval 0.0 to 19.0

PRIMARY outcome

Timeframe: Week 12

Outcome measures

Measure	Memantine and Vivitrol n=28 Participants intramuscular injection of Vivitrol 380 mg and 20 mg bid Memantine (PO) Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections) 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.	Placebo and Vivitrol n=27 Participants intramuscular injection of Vivitrol 380 mg and Placebo Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)
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).	12 participants	19 participants

SECONDARY outcome

Timeframe: Average of twice weekly assessments for 12 weeks of study or length of participation

Range 0- 100 ( 0= no craving; 100= very strong craving

Outcome measures

Measure	Memantine and Vivitrol n=27 Participants intramuscular injection of Vivitrol 380 mg and 20 mg bid Memantine (PO) Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections) 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.	Placebo and Vivitrol n=28 Participants intramuscular injection of Vivitrol 380 mg and Placebo Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)
Opiate Craving Based on Heroin Craving Scale	18.47 units on a scale Standard Deviation 25.79	15.74 units on a scale Standard Deviation 22.22

Adverse Events

Memantine and Vivitrol

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

Placebo and Vivitrol

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Measure	Memantine and Vivitrol n=28 participants at risk intramuscular injection of Vivitrol 380 mg and 20 mg bid Memantine (PO) Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections) 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.	Placebo and Vivitrol n=27 participants at risk intramuscular injection of Vivitrol 380 mg and Placebo Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)
Psychiatric disorders Psychiatric worsening	3.6% 1/28	0.00% 0/27

Other adverse events

Measure	Memantine and Vivitrol n=28 participants at risk intramuscular injection of Vivitrol 380 mg and 20 mg bid Memantine (PO) Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections) 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.	Placebo and Vivitrol n=27 participants at risk intramuscular injection of Vivitrol 380 mg and Placebo Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)
Psychiatric disorders Insomnia	60.7% 17/28 • Number of events 17	48.1% 13/27 • Number of events 13
Psychiatric disorders Mood changes	25.0% 7/28 • Number of events 7	33.3% 9/27 • Number of events 9
Psychiatric disorders Increased/decreased appetite	21.4% 6/28 • Number of events 6	18.5% 5/27 • Number of events 5
Psychiatric disorders Fatigue/drowsiness	25.0% 7/28 • Number of events 7	29.6% 8/27 • Number of events 8
Psychiatric disorders Nausea/Vomiting	3.6% 1/28 • Number of events 1	14.8% 4/27 • Number of events 4
Psychiatric disorders Diarrhea	25.0% 7/28 • Number of events 7	11.1% 3/27 • Number of events 3
Psychiatric disorders Headache	7.1% 2/28 • Number of events 2	14.8% 4/27 • Number of events 4
Psychiatric disorders Body Aches	14.3% 4/28 • Number of events 4	22.2% 6/27 • Number of events 6
Psychiatric disorders GI Distress	14.3% 4/28 • Number of events 4	25.9% 7/27 • Number of events 7
Psychiatric disorders Sweating/chills	7.1% 2/28 • Number of events 2	18.5% 5/27 • Number of events 5
Psychiatric disorders Faintness/dizziness	7.1% 2/28 • Number of events 2	11.1% 3/27 • Number of events 3

Additional Information

Adam Bisaga

NYS Psychiatric Institute

Phone: 646-774-6155

Email: amb107@columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place