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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01262092
Other study ID # R01-DA010017-pilot
Secondary ID 112714R01DA01001
Status Completed
Phase Phase 2
First received December 15, 2010
Last updated June 19, 2013
Start date October 2010
Est. completion date January 2012

Study information

Verified date June 2013
Source University of Arkansas
Contact n/a
Is FDA regulated No
Health authority United States: Federal GovernmentUnited States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This study involves inducting treatment seeking opioid dependent participants onto buprenorphine. Once the participant reaches a stable dose they will receive either placebo or gabapentin to determine if gabapentin helps ease withdrawal symptoms while the participant undergoes a 10-day buprenorphine detoxification.


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Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

Drug:
Buprenorphine
Induction onto buprenorphine to a stable dose of 12mg/day. Then induction onto either 0 or 1600mg of gabapentin. Once the maintenance dose of gabapentin is reached a 10-day buprenorphine detoxification will begin.

Locations

Country Name City State
United States University of Arkansas for Medical Sciences Little Rock Arkansas

Sponsors (2)

Lead Sponsor Collaborator
University of Arkansas National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Illicit Opioid Use as Determine by Urine Dipsticks urine data are from those obtained during the buprenorphine taper 3x weekly during wks 3 and 4 No
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