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

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ClinicalTrials.gov Identifier: NCT01262092
Recruitment Status : Completed
First Posted : December 17, 2010
Results First Posted : June 21, 2013
Last Update Posted : June 21, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Opioid Dependence Opioid Withdrawal Opioid Detoxification Drug: Buprenorphine Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Gabapentin Versus Placebo on Buprenorphine Detoxification of Opioid-dependent Individuals
Study Start Date : October 2010
Primary Completion Date : December 2011
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Gabapentin
Buprenorphine will be given along with 2 capsules of gabapentin in the morning and 2 take-home capsules of gabapentin for night.
Drug: 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.
Other Name: Neurontin, Suboxone,
Placebo Comparator: Placebo
Buprenorphine will be given, with 2 capsules of placebo in the morning and 2 take-home capsules of placebo in the evening
Drug: 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.
Other Name: Neurontin, Suboxone,


Outcome Measures

Primary Outcome Measures :
  1. Illicit Opioid Use as Determine by Urine Dipsticks [ Time Frame: 3x weekly during wks 3 and 4 ]
    urine data are from those obtained during the buprenorphine taper


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01262092


Locations
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Alison Oliveto, Ph.D. UAMS Center for Addiction Research
More Information

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01262092     History of Changes
Other Study ID Numbers: R01-DA010017-pilot
112714 ( Other Identifier: UAMS IRB )
R01DA010017 ( U.S. NIH Grant/Contract )
First Posted: December 17, 2010    Key Record Dates
Results First Posted: June 21, 2013
Last Update Posted: June 21, 2013
Last Verified: June 2013

Keywords provided by University of Arkansas:
opioid dependent
detoxification
buprenorphine
suboxone
opiate

Additional relevant MeSH terms:
Analgesics, Opioid
Buprenorphine
Buprenorphine, Naloxone Drug Combination
Gabapentin
gamma-Aminobutyric Acid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents