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

Opioid Dependence Clinical Trial

— Detox  

Official title:

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Opioid Dependence
• Opioid Detoxification
• Opioid Withdrawal

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