Effects of Gabapentin Versus Placebo on Buprenorphine Detoxification of Opioid-dependent Individuals

Phase 2

Completed

• Conditions: Opioid Dependence; Opioid Withdrawal; Opioid Detoxification
• Interventions: Drug: Buprenorphine

• Registration Number: NCT01262092
• Lead Sponsor: University of Arkansas

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-12-15
• Study First Submitted QC: 2010-12-15
• Study First Posted: 2010-12-17
• Primary Completion: 2011-12
• Study Completion: 2012-01
• Results First Submitted: 2013-02-04
• Status Verified: 2013-06
• Results First Submitted QC: 2013-06-19
• Last Update Submitted: 2013-06-19
• Results First Posted: 2013-06-21
• Last Update Posted: 2013-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Availability to attend clinic 6 days a week for approximately 30-60 minutes.
• Participants must fulfill DSM-IV criteria for opioid dependence. These criteria will be ascertained in the following manner: the physician will determine whether the individual is appropriate based on several clinical assessments that are routinely employed by methadone program physicians, including history and severity of opioid use, presence of track marks, prior treatment history, self-reported and/or observed signs and symptoms of opioid withdrawal. If any individual's degree of opioid dependence is questionable, that person will be excluded from further consideration as a participant.
• Participants must submit a urine negative for drugs of abuse other than opioids prior to starting the study.

Exclusion Criteria

• Unstable medical condition or stable medical condition that would interact with study medications or participation.
• History of major psychiatric disorder (psychosis, schizophrenia, bipolar, depression)
• Pregnancy or plans to become pregnant or inadequate birth control (adequate birth control includes abstinence, condoms, birth control pills, etc).
• Present or recent use of over-the-counter psychoactive drug, prescription psychoactive drug or drug (including Maalox) that would have major interaction with drugs to be tested.
• Liver function tests greater than 3 times normal, BUN and Creatinine outside normal range, or thyroid function tests outside normal range.
• EKG abnormalities including but not limited to: bradycardia (<60 bpm); prolonged QTc interval (>450 msec); Wolff-Parkinson White syndrome; wide complex tachycardia; 2nd degree, Mobitz type II heart block; 3rd degree heart block; left or right bundle branch block.
• Physical dependence on alcohol or drugs other than opioids or tobacco (as determined by physician assessment).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gabapentin	Buprenorphine	Buprenorphine will be given along with 2 capsules of gabapentin in the morning and 2 take-home capsules of gabapentin for night.
Placebo	Buprenorphine	Buprenorphine will be given, with 2 capsules of placebo in the morning and 2 take-home capsules of placebo in the evening

Primary Outcome Measures

Name	Time	Method
Illicit Opioid Use as Determine by Urine Dipsticks	3x weekly during wks 3 and 4	urine data are from those obtained during the buprenorphine taper

Trial Locations

Locations (1)

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States