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

University of Arkansas

Status and phase

Completed

Phase 2

Conditions

Opioid Withdrawal

Opioid Detoxification

Opioid Dependence

Treatments

Drug: Buprenorphine

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01262092

R01-DA010017-pilot

112714 (Other Identifier)

R01DA010017 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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).