Effects of Buspirone in Opiate Withdrawal
Condition: Heroin Dependence
MeSH terms: Heroin Dependence
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Buspirone
Intervention type(s): Drug
Intervention MeSH terms: Buspirone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Opioid withdrawal; Buspirone; Methadone taper