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

Primary Purpose

Opioid Dependence, Opioid Withdrawal, Opioid Detoxification

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Dependence focused on measuring opioid dependent, detoxification, buprenorphine, suboxone, opiate

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • University of Arkansas for Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Gabapentin

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Illicit Opioid Use as Determine by Urine Dipsticks
urine data are from those obtained during the buprenorphine taper

Secondary Outcome Measures

Full Information

First Posted
December 15, 2010
Last Updated
June 19, 2013
Sponsor
University of Arkansas
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01262092
Brief Title
Effects of Gabapentin Versus Placebo on Buprenorphine Detoxification of Opioid-dependent Individuals
Acronym
Detox
Official Title
Effects of Gabapentin Versus Placebo on Buprenorphine Detoxification of Opioid-dependent Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Dependence, Opioid Withdrawal, Opioid Detoxification
Keywords
opioid dependent, detoxification, buprenorphine, suboxone, opiate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gabapentin
Arm Type
Active Comparator
Arm Description
Buprenorphine will be given along with 2 capsules of gabapentin in the morning and 2 take-home capsules of gabapentin for night.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Buprenorphine will be given, with 2 capsules of placebo in the morning and 2 take-home capsules of placebo in the evening
Intervention Type
Drug
Intervention Name(s)
Buprenorphine
Other Intervention Name(s)
Neurontin, Suboxone,
Intervention Description
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.
Primary Outcome Measure Information:
Title
Illicit Opioid Use as Determine by Urine Dipsticks
Description
urine data are from those obtained during the buprenorphine taper
Time Frame
3x weekly during wks 3 and 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alison Oliveto, Ph.D.
Organizational Affiliation
UAMS Center for Addiction Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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