Effects of Gabapentin Versus Placebo on Buprenorphine Detoxification of Opioid-dependent Individuals
This study has been completed.
Sponsor:
University of Arkansas
Collaborator:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01262092
First received: December 15, 2010
Last updated: March 16, 2012
Last verified: March 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Opioid Dependent Individuals Seeking Treatment |
Drug: Buprenorphine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Effects of Gabapentin Versus Placebo on Buprenorphine Detoxification of Opioid-dependent Individuals |
Resource links provided by NLM:
Drug Information available for:
Buprenorphine
Buprenorphine hydrochloride
Gabapentin
Gabapentin enacarbil
U.S. FDA Resources
Further study details as provided by University of Arkansas:
Primary Outcome Measures:
- Illicit drug use as determine by urine dipsticks [ Time Frame: 3x weekly for 4 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Weekly drug use and craving scales [ Time Frame: once weekly for 5 weeks ] [ Designated as safety issue: No ]
- Self-reports of Opioid withdrawal symptoms [ Time Frame: 3x weekly 5 weeks ] [ Designated as safety issue: No ]
- observer rated opioid withdrawal symptoms [ Time Frame: 3x weekly 5 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 30 |
| Study Start Date: | October 2010 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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,
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01262092
Locations
| United States, Arkansas | |
| University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
Sponsors and Collaborators
University of Arkansas
Investigators
| Principal Investigator: | Alison Oliveto, Ph.D. | UAMS Center for Addiction Research |
More Information
No publications provided
| Responsible Party: | University of Arkansas |
| ClinicalTrials.gov Identifier: | NCT01262092 History of Changes |
| Other Study ID Numbers: | R01-DA010017-pilot, 112714, R01DA010017 |
| Study First Received: | December 15, 2010 |
| Last Updated: | March 16, 2012 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by University of Arkansas:
|
opioid dependent detoxification buprenorphine suboxone opiate |
Additional relevant MeSH terms:
|
Buprenorphine Analgesics, Opioid Gabapentin Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotic Antagonists Narcotics Anticonvulsants |
Antiparkinson Agents Anti-Dyskinesia Agents Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Antimanic Agents |
ClinicalTrials.gov processed this record on May 22, 2013