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

Information source: University of Arkansas
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Opioid Dependence; Opioid Withdrawal; Opioid Detoxification

Intervention: Buprenorphine (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: University of Arkansas

Official(s) and/or principal investigator(s):
Alison Oliveto, Ph.D., Principal Investigator, Affiliation: UAMS Center for Addiction Research

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.

Clinical Details

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

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

Primary outcome: Illicit Opioid Use as Determine by Urine Dipsticks

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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).

Locations and Contacts

University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205, United States
Additional Information

Starting date: October 2010
Last updated: June 19, 2013

Page last updated: August 23, 2015

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