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

NCT01262092 | Completed Phase 2 Results DMC

• 3 other identifiers: R01-DA010017-pilot112714R01DA010017
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

opioid dependent; detoxification; buprenorphine; suboxone; opiate

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Gabapentin

ACTIVE COMPARATOR

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

Drug: Buprenorphine

Placebo

PLACEBO COMPARATOR

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

Drug: Buprenorphine

Interventions

Buprenorphine 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.

Also known as: Neurontin, Suboxone,

Gabapentin; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Arkansas: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine; Gabapentin; Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Naloxone; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Alison Oliveto
• Organization: University of Arkansas for Medical Sciences

olivetoalison@uams.edu

501-526-8441

Study Officials

• Alison Oliveto, Ph.D.

  UAMS Center for Addiction Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2010
• First Posted: December 17, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: June 21, 2013
• Results First Posted: June 21, 2013

Record last verified: 2013-06

Locations

US (1)