NCT00326235

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 2002

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 16, 2006

Completed
Last Updated

January 12, 2017

Status Verified

March 1, 2005

First QC Date

May 12, 2006

Last Update Submit

January 11, 2017

Conditions

Heroin Dependence

Keywords

Opioid withdrawalBuspironeMethadone taper

Interventions

BuspironeDRUG

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA New York Harbor Healthcare System - Brooklyn Campus

Brooklyn, New York, 11209, United States

Location

Related Publications (1)

  • 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.

    PMID: 15876901RESULT

MeSH Terms

Conditions

Heroin Dependence

Interventions

Buspirone

Condition Hierarchy (Ancestors)

Opioid-Related DisordersNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Spiro CompoundsHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesPolycyclic Compounds

Study Officials

  • Laure Buydens-Branchey, M.D.

    VA New York Harbor Healthcare System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

May 12, 2006

First Posted

May 16, 2006

Study Start

January 1, 2002

Study Completion

July 1, 2004

Last Updated

January 12, 2017

Record last verified: 2005-03

Locations

US(1)