Trial Outcomes & Findings for Memantine and Naltrexone Treatment for Opioid Dependence (NCT NCT00125515)

NCT ID: NCT00125515

Last Updated: 2018-06-18

Results Overview

The number of participants who were retained and completed all 12 weeks of treatment and study participation were compared between the three study groups.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 81 participants
• Primary outcome timeframe: Number of participants who complete 12 weeks of treatment
• Results posted on: 2018-06-18

Participant Flow

Individuals who applied for treatment at the Columbia University's Substance Treatment and Research Service outpatient clinic in New York City were recruited for this study.

Following consent participants were admitted to an inpatient unti at NYSPI for the purpose od detoxification and naltrexone induction. On the second day of induction they were randomized to a study arm.

Participant milestones

Measure	Placebo Placebo plus oral naltrexone	Memantine 30 mg Bid Memantine 30 mg bid plus oral naltrexone	Memantine 15 mg Bid memantine 15 mg bid plus oral naltrexone
Overall Study STARTED	27	27	27
Overall Study COMPLETED	7	7	6
Overall Study NOT COMPLETED	20	20	21

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Memantine and Naltrexone Treatment for Opioid Dependence

Baseline characteristics by cohort

Measure	Placebo n=27 Participants Placebo plus oral naltrexone	Memantine 30 mg Bid n=27 Participants Memantine 30 mg bid plus oral naltrexone	Memantine 15 mg Bid n=27 Participants memantine 15 mg bid plus oral naltrexone	Total n=81 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants	27 Participants n=7 Participants	27 Participants n=5 Participants	81 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	40.5 years STANDARD_DEVIATION 9.6 • n=5 Participants	42.0 years STANDARD_DEVIATION 10.3 • n=7 Participants	41.5 years STANDARD_DEVIATION 9.4 • n=5 Participants	41.3 years STANDARD_DEVIATION 9.8 • n=4 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	15 Participants n=4 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	22 Participants n=7 Participants	24 Participants n=5 Participants	66 Participants n=4 Participants
Region of Enrollment United States	27 participants n=5 Participants	27 participants n=7 Participants	27 participants n=5 Participants	81 participants n=4 Participants

PRIMARY outcome

Timeframe: Number of participants who complete 12 weeks of treatment

Population: All analysis were conducted based on intent-to-treat principle.

The number of participants who were retained and completed all 12 weeks of treatment and study participation were compared between the three study groups.

Outcome measures

Measure	Placebo n=27 Participants Placebo plus oral naltrexone	Memantine 30 mg Bid n=27 Participants Memantine 30 mg bid plus oral naltrexone	Memantine 15 mg Bid n=27 Participants memantine 15 mg bid plus oral naltrexone
Retention in Treatment	7 participants	5 participants	6 participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Memantine 30 mg Bid

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Memantine 15 mg Bid

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=27 participants at risk Placebo plus oral naltrexone	Memantine 30 mg Bid n=27 participants at risk Memantine 30 mg bid plus oral naltrexone	Memantine 15 mg Bid n=27 participants at risk memantine 15 mg bid plus oral naltrexone
General disorders heroin overdose	0.00% 0/27	0.00% 0/27	3.7% 1/27 • Number of events 1

Other adverse events

Measure	Placebo n=27 participants at risk Placebo plus oral naltrexone	Memantine 30 mg Bid n=27 participants at risk Memantine 30 mg bid plus oral naltrexone	Memantine 15 mg Bid n=27 participants at risk memantine 15 mg bid plus oral naltrexone
General disorders headache	18.5% 5/27 • Number of events 5	11.1% 3/27 • Number of events 3	7.4% 2/27 • Number of events 2
General disorders insomnia	25.9% 7/27 • Number of events 7	33.3% 9/27 • Number of events 9	29.6% 8/27 • Number of events 8
General disorders body aches	7.4% 2/27 • Number of events 2	7.4% 2/27 • Number of events 2	3.7% 1/27 • Number of events 1
General disorders dizziness	11.1% 3/27 • Number of events 3	7.4% 2/27 • Number of events 2	7.4% 2/27 • Number of events 2
Gastrointestinal disorders nausea	3.7% 1/27 • Number of events 1	18.5% 5/27 • Number of events 5	3.7% 1/27 • Number of events 1
General disorders weakness	3.7% 1/27 • Number of events 1	3.7% 1/27 • Number of events 1	11.1% 3/27 • Number of events 3
Gastrointestinal disorders diarrhea	14.8% 4/27 • Number of events 4	14.8% 4/27 • Number of events 4	7.4% 2/27 • Number of events 2
Gastrointestinal disorders GI distress	25.9% 7/27 • Number of events 7	25.9% 7/27 • Number of events 7	0.00% 0/27

Additional Information

Dr Adam Bisaga

New York Psychiatric Institute

Phone: 212-543-6542

Email: bisagaa@nyspi.columbia.edu

Results disclosure agreements

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