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Gabapentin Treatment of Benzodiazepine Dependence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01893632
Recruitment Status : Terminated (Insufficient recruitment, funding terminated from sponsor)
First Posted : July 9, 2013
Results First Posted : July 24, 2018
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
John Mariani MD, New York State Psychiatric Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Benzodiazepine Dependence
Interventions Drug: gabapentin
Drug: Placebo
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Gabapentin Placebo
Hide Arm/Group Description

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

Capsules filled with riboflavin.

Placebo

Period Title: Overall Study
Started 1 1
Completed 1 1
Not Completed 0 0
Arm/Group Title Gabapentin Placebo Total
Hide Arm/Group Description

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

Capsules filled with riboflavin.

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 1 1 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants 1 participants 2 participants
59  (0) 59  (0) 59  (0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
Female
0
   0.0%
1
 100.0%
1
  50.0%
Male
1
 100.0%
0
   0.0%
1
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
Hispanic or Latino
0
   0.0%
1
 100.0%
1
  50.0%
Not Hispanic or Latino
1
 100.0%
0
   0.0%
1
  50.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
1
 100.0%
0
   0.0%
1
  50.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
 100.0%
1
  50.0%
1.Primary Outcome
Title Abstinence From Benzodiazepine Use
Hide Description Achievement of two weeks abstinence from benzodiazepine use at end of trial
Time Frame last two weeks of 12 week trial
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gabapentin Placebo
Hide Arm/Group Description:

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

Capsules filled with riboflavin.

Placebo

Overall Number of Participants Analyzed 1 1
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Time Frame 12 weeks of trial
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Gabapentin Placebo
Hide Arm/Group Description

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

Capsules filled with riboflavin.

Placebo

All-Cause Mortality
Gabapentin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)      0/1 (0.00%)    
Hide Serious Adverse Events
Gabapentin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/1 (0.00%)      0/1 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Gabapentin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/1 (100.00%)      1/1 (100.00%)    
Gastrointestinal disorders     
appetite change   0/1 (0.00%)  0 1/1 (100.00%)  1
nausea   0/1 (0.00%)  0 1/1 (100.00%)  1
General disorders     
anxiety   0/1 (0.00%)  0 1/1 (100.00%)  1
chest tightness   0/1 (0.00%)  0 1/1 (100.00%)  1
confusion   1/1 (100.00%)  1 0/1 (0.00%)  0
sensory overstimulation   0/1 (0.00%)  0 1/1 (100.00%)  1
Musculoskeletal and connective tissue disorders     
unsteady gait   1/1 (100.00%)  1 0/1 (0.00%)  0
coordination issues   1/1 (100.00%)  1 0/1 (0.00%)  0
Indicates events were collected by systematic assessment
due to poor recruitment, enrollment was limited to two participants and trial was terminated.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: john mariani, md
Organization: NYSPI
Phone: 646-774-6140
EMail: john.mariani@nyspi.columbia.edu
Layout table for additonal information
Responsible Party: John Mariani MD, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01893632    
Other Study ID Numbers: 6740
First Submitted: June 29, 2013
First Posted: July 9, 2013
Results First Submitted: June 27, 2018
Results First Posted: July 24, 2018
Last Update Posted: April 24, 2019