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Effects of Buspirone in Opiate Withdrawal

Primary Purpose

Heroin Dependence

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Buspirone
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heroin Dependence focused on measuring Opioid withdrawal, Buspirone, Methadone taper

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA New York Harbor Healthcare System - Brooklyn Campus

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 12, 2006
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00326235
Brief Title
Effects of Buspirone in Opiate Withdrawal
Official Title
Effects of Buspirone in Withdrawal From Opiates
Study Type
Interventional

2. Study Status

Record Verification Date
March 2005
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Drug Abuse (NIDA)

4. Oversight

5. Study Description

Brief Summary
Dependence on heroin is a major public health problem because of its association with criminality, law enforcement costs and healthcare costs. Managed withdrawal is a required first step for a long term drug-free treatment of heroin addicts. Methadone and clonidine have been the mainstay of treatment for the relief of heroin withdrawal symptoms but both have limitations. The purpose of this study was to evaluate the efficacy of buspirone in the alleviation of the withdrawal symptoms experienced by heroin addicts when they stop using heroin. Buspirone is a non opiate drug with no abuse potential, no sedating effects and no withdrawal symptoms.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heroin Dependence
Keywords
Opioid withdrawal, Buspirone, Methadone taper

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Buspirone

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laure Buydens-Branchey, M.D.
Organizational Affiliation
VA New York Harbor Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA New York Harbor Healthcare System - Brooklyn Campus
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11209
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15876901
Citation
Buydens-Branchey L, Branchey M, Reel-Brander C. Efficacy of buspirone in the treatment of opioid withdrawal. J Clin Psychopharmacol. 2005 Jun;25(3):230-6. doi: 10.1097/01.jcp.0000162804.38829.97.
Results Reference
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Effects of Buspirone in Opiate Withdrawal

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