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

NCT ID: NCT01262092

Last Updated: 2013-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-01-31

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.

Conditions

Opioid Dependence; Opioid Withdrawal; Opioid Detoxification

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Gabapentin

Buprenorphine will be given along with 2 capsules of gabapentin in the morning and 2 take-home capsules of gabapentin for night.

Group Type: ACTIVE_COMPARATOR

Buprenorphine

Intervention Type: DRUG

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.

Placebo

Buprenorphine will be given, with 2 capsules of placebo in the morning and 2 take-home capsules of placebo in the evening

Group Type: PLACEBO_COMPARATOR

Buprenorphine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Neurontin, Suboxone,

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alison Oliveto, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

UAMS Center for Addiction Research

Locations

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Countries

United States

Other Identifiers

112714

Identifier Type: OTHER

Identifier Source: secondary_id

R01DA010017

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01-DA010017-pilot

Identifier Type: -

Identifier Source: org_study_id