Trial Outcomes & Findings for Gabapentin Treatment of Benzodiazepine Abuse in Methadone Maintenance Patients (NCT NCT00420771)

NCT ID: NCT00420771

Last Updated: 2019-04-24

Results Overview

Comparing the mean reduction change in Benzodiazepine use per day when comparing the baseline week prior to study entry to the last week of study participation based on the Time Line Follow Back

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 19 participants
• Primary outcome timeframe: data collected during 8 weeks of trial or length of participation
• Results posted on: 2019-04-24

Participant Flow

Participant milestones

Measure	Gabapentin gabapentin treatment 1200 mg three times daily	Placebo Placebo condition received pills identical in appearance to experimental arm.
Overall Study STARTED	8	11
Overall Study COMPLETED	5	7
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Gabapentin Treatment of Benzodiazepine Abuse in Methadone Maintenance Patients

Baseline characteristics by cohort

Measure	Gabapentin n=8 Participants gabapentin treatment 1200 mg three times daily	Placebo n=11 Participants Placebo condition received pills identical in appearance to experimental arm.	Total n=19 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
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	11 participants n=7 Participants	19 participants n=5 Participants

PRIMARY outcome

Timeframe: data collected during 8 weeks of trial or length of participation

Population: a total of 16 participants had data available post randomization

Comparing the mean reduction change in Benzodiazepine use per day when comparing the baseline week prior to study entry to the last week of study participation based on the Time Line Follow Back

Outcome measures

Measure	Active Medication n=6 Participants gabapentin treatment 1200 mg three times daily Gabapentin: For the first week, one 400 mg Gabapentin capsule taken 3 times per day. For the second week, two 400 mg Gabapentin capsules taken 3 times per day. For the third week through the eighth week, three 400 mg Gabapentin capsules taken 3 times per day. For the ninth and last week, two 400 mg Gabapentin capsules taken 3 times per day for 3 days, then one 400 mg Gabapentin capsule taken 3 times per day for 4 days. Placebo study medication appears identical to active medication and is prescribed with an identical dosing schedule.	Placebo n=10 Participants Placebo condition received pills identical in appearance to experimental arm. Gabapentin: For the first week, one 400 mg Gabapentin capsule taken 3 times per day. For the second week, two 400 mg Gabapentin capsules taken 3 times per day. For the third week through the eighth week, three 400 mg Gabapentin capsules taken 3 times per day. For the ninth and last week, two 400 mg Gabapentin capsules taken 3 times per day for 3 days, then one 400 mg Gabapentin capsule taken 3 times per day for 4 days. Placebo study medication appears identical to active medication and is prescribed with an identical dosing schedule.
Mean Reduction Change in Benzodiazepine Use Per Day Based on Time Line Follow Back	4.0 milligrams/day Standard Deviation 4.0	2.3 milligrams/day Standard Deviation 6.7

Adverse Events

Gabapentin

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Gabapentin n=6 participants at risk gabapentin treatment 1200 mg three times daily	Placebo n=10 participants at risk Placebo condition received pills identical in appearance to experimental arm.
General disorders fatigue	50.0% 3/6 • Number of events 3 • 8 weeks of study	20.0% 2/10 • Number of events 2 • 8 weeks of study
General disorders somnalence	83.3% 5/6 • Number of events 5 • 8 weeks of study	20.0% 2/10 • Number of events 2 • 8 weeks of study
General disorders dizziness	66.7% 4/6 • Number of events 4 • 8 weeks of study	0.00% 0/10 • 8 weeks of study
General disorders other	0.00% 0/6 • 8 weeks of study	10.0% 1/10 • Number of events 1 • 8 weeks of study

Additional Information

John J. Mariani, MD

NYSPI

Phone: 212-543-5987

Email: jm2330@columbia.edu

Results disclosure agreements

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