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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01262092 |
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Date of registration:
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15/12/2010 |
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Primary sponsor: |
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Public title:
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Effects of Gabapentin Versus Placebo on Buprenorphine Detoxification of Opioid-dependent Individuals
Detox |
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Scientific title:
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Effects of Gabapentin Versus Placebo on Buprenorphine Detoxification of Opioid-dependent Individuals |
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Date of first enrolment:
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October 2010 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01262092 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Alison Oliveto, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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UAMS Center for Addiction Research |
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Key inclusion & exclusion criteria
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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).
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Opioid Dependent Individuals Seeking Treatment
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Intervention(s)
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Drug: Buprenorphine
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Primary Outcome(s)
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Illicit drug use as determine by urine dipsticks
[Time Frame: 3x weekly for 4 weeks]
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Secondary Outcome(s)
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observer rated opioid withdrawal symptoms
[Time Frame: 3x weekly 5 weeks]
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Self-reports of Opioid withdrawal symptoms
[Time Frame: 3x weekly 5 weeks]
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Weekly drug use and craving scales
[Time Frame: once weekly for 5 weeks]
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Secondary ID(s)
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112714
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R01-DA010017-pilot
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R01DA010017
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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