Effects of Buspirone in Opiate Withdrawal

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00326235
First received: May 12, 2006
Last updated: NA
Last verified: March 2005
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Heroin Dependence
Drug: Buspirone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effects of Buspirone in Withdrawal From Opiates

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Study Start Date: January 2002
Estimated Study Completion Date: July 2004
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.

  Eligibility

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00326235

Locations
United States, New York
VA New York Harbor Healthcare System - Brooklyn Campus
Brooklyn, New York, United States, 11209
Sponsors and Collaborators
Investigators
Principal Investigator: Laure Buydens-Branchey, M.D. VA New York Harbor Healthcare System
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00326235     History of Changes
Other Study ID Numbers: R01DA13264
Study First Received: May 12, 2006
Last Updated: May 12, 2006
Health Authority: United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):
Opioid withdrawal
Buspirone
Methadone taper

Additional relevant MeSH terms:
Heroin Dependence
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buspirone
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 27, 2014