- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00326235
Effects of Buspirone in Opiate Withdrawal
Effects of Buspirone in Withdrawal From Opiates
Study Overview
Detailed Description
In an attempt to develop a new opiate detoxification approach, the authors assessed the efficacy of buspirone in the treatment of acute heroin withdrawal. Buspirone, a drug interacting with the serotonergic system was selected because there is evidence that a decrease in serotonergic neurotransmission may be involved in opiate withdrawal symptomatology.
Hospitalized heroin addicts were randomized to 4 groups: 1) placebo; 2) methadone; 3) buspirone 30 mg daily; 4) buspirone 45 mg daily. The double-blind trial started in all patients with a 5-day methadone stabilization period ending with a 30 mg dose. This was followed from day 6 through 12 by placebo in group 1 and by a methadone taper in group 2. Because of its delayed action, buspirone was started on day 1 in groups 3 and 4 and was continued, after methadone discontinuation, through day 12. On day 13, drugs and placebo were discontinued and patients observed through day 14. Withdrawal symptoms were assessed with the "Subjective Opiate Withdrawal Scale" (SOWS) and the "Objective Opiate Withdrawal Scale" (OOWS). Participants met with a research assistant daily for 30 minutes while on an inpatient unit. The study did not interfere with the scheduled ward activities. Results so far indicate that the SOWS and OOWS scores were significantly higher in the Placebo group than in the Methadone, Buspirone 30 mg and Buspirone 45 mg groups. There were no significant differences in SOWS or OOWS scores when the Methadone group was compared to each of the two Buspirone groups or when the two Buspirone groups were compared to one another. Thus buspirone, a non opiate drug with no abuse potential, a safe side effect profile and no withdrawal symptoms at doses of 30 and 45 mg, was as effective as a methadone taper in alleviating the withdrawal symptoms of heroin addicts stabilized for 5 days with, and then withdrawn from, methadone. Additional analyses will be performed using data collected in the course of the study.
Study Type
Phase
- Phase 4
Contacts and Locations
Study Locations
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New York
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Brooklyn, New York, United States, 11209
- VA New York Harbor Healthcare System - Brooklyn Campus
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- fulfilled DSM IV diagnostic criteria for opioid dependence
- used heroin daily for at least the prior 6 months with claimed heroin use of at least 2.5g/week
- physical dependence on opiates as determined by history and observation
- admission urine samples demonstrating heroin use
- expressed willingness to participate in a randomized, double-blind, placebo-controlled study for 14 days.
Exclusion Criteria:
- current or past Axis I psychiatric disorder other than opioid dependence
- evidence of significant neurological, gastrointestinal, hepatic, cardiovascular, renal, endocrine or hematologic disease
- seropositive status for the human immunodeficiency virus
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
Investigators
- Principal Investigator: Laure Buydens-Branchey, M.D., VA New York Harbor Healthcare System
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Narcotic-Related Disorders
- Opioid-Related Disorders
- Heroin Dependence
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Serotonin Receptor Agonists
- Anti-Anxiety Agents
- Buspirone
Other Study ID Numbers
- R01DA013264 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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