Trial Outcomes & Findings for Gabapentin Treatment of Benzodiazepine Dependence (NCT NCT01893632)
NCT ID: NCT01893632
Last Updated: 2019-04-24
Results Overview
Achievement of two weeks abstinence from benzodiazepine use at end of trial
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
2 participants
Primary outcome timeframe
last two weeks of 12 week trial
Results posted on
2019-04-24
Participant Flow
Participant milestones
| Measure |
Gabapentin
All study medication will be over-capsulated with riboflavin to assess compliance using quantitative fluoroscopy. All participants will take three capsules three times per day throughout the study period. During week 1, GBP will be titrated over a five-day period to the dose target (GBP 1200 mg three times daily) or the maximum tolerated dose. Medication dosing will continue at GBP 1200 mg three times daily or placebo through the end of the study period (week 12). Dose reductions will be made for tolerability if necessary.
gabapentin
|
Placebo
Capsules filled with riboflavin.
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gabapentin Treatment of Benzodiazepine Dependence
Baseline characteristics by cohort
| Measure |
Gabapentin
n=1 Participants
All study medication will be over-capsulated with riboflavin to assess compliance using quantitative fluoroscopy. All participants will take three capsules three times per day throughout the study period. During week 1, GBP will be titrated over a five-day period to the dose target (GBP 1200 mg three times daily) or the maximum tolerated dose. Medication dosing will continue at GBP 1200 mg three times daily or placebo through the end of the study period (week 12). Dose reductions will be made for tolerability if necessary.
gabapentin
|
Placebo
n=1 Participants
Capsules filled with riboflavin.
Placebo
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 0 • n=5 Participants
|
59 years
STANDARD_DEVIATION 0 • n=7 Participants
|
59 years
STANDARD_DEVIATION 0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: last two weeks of 12 week trialAchievement of two weeks abstinence from benzodiazepine use at end of trial
Outcome measures
| Measure |
Gabapentin
n=1 Participants
All study medication will be over-capsulated with riboflavin to assess compliance using quantitative fluoroscopy. All participants will take three capsules three times per day throughout the study period. During week 1, GBP will be titrated over a five-day period to the dose target (GBP 1200 mg three times daily) or the maximum tolerated dose. Medication dosing will continue at GBP 1200 mg three times daily or placebo through the end of the study period (week 12). Dose reductions will be made for tolerability if necessary.
gabapentin
|
Placebo
n=1 Participants
Capsules filled with riboflavin.
Placebo
|
|---|---|---|
|
Abstinence From Benzodiazepine Use
|
0 Participants
|
0 Participants
|
Adverse Events
Gabapentin
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Gabapentin
n=1 participants at risk
All study medication will be over-capsulated with riboflavin to assess compliance using quantitative fluoroscopy. All participants will take three capsules three times per day throughout the study period. During week 1, GBP will be titrated over a five-day period to the dose target (GBP 1200 mg three times daily) or the maximum tolerated dose. Medication dosing will continue at GBP 1200 mg three times daily or placebo through the end of the study period (week 12). Dose reductions will be made for tolerability if necessary.
gabapentin
|
Placebo
n=1 participants at risk
Capsules filled with riboflavin.
Placebo
|
|---|---|---|
|
General disorders
anxiety
|
0.00%
0/1 • 12 weeks of trial
|
100.0%
1/1 • Number of events 1 • 12 weeks of trial
|
|
Gastrointestinal disorders
appetite change
|
0.00%
0/1 • 12 weeks of trial
|
100.0%
1/1 • Number of events 1 • 12 weeks of trial
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/1 • 12 weeks of trial
|
100.0%
1/1 • Number of events 1 • 12 weeks of trial
|
|
Musculoskeletal and connective tissue disorders
unsteady gait
|
100.0%
1/1 • Number of events 1 • 12 weeks of trial
|
0.00%
0/1 • 12 weeks of trial
|
|
General disorders
chest tightness
|
0.00%
0/1 • 12 weeks of trial
|
100.0%
1/1 • Number of events 1 • 12 weeks of trial
|
|
General disorders
confusion
|
100.0%
1/1 • Number of events 1 • 12 weeks of trial
|
0.00%
0/1 • 12 weeks of trial
|
|
Musculoskeletal and connective tissue disorders
coordination issues
|
100.0%
1/1 • Number of events 1 • 12 weeks of trial
|
0.00%
0/1 • 12 weeks of trial
|
|
General disorders
sensory overstimulation
|
0.00%
0/1 • 12 weeks of trial
|
100.0%
1/1 • Number of events 1 • 12 weeks of trial
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place