Overview

Effects of Buspirone in Opiate Withdrawal

Status:
Completed
Trial end date:
2004-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Treatments:
Buspirone
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