Effects of Buspirone in Opiate Withdrawal



Status:Completed
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:25 - 55
Updated:1/13/2017
Start Date:January 2002
End Date:July 2004

Use our guide to learn which trials are right for you!

Effects of Buspirone in Withdrawal From Opiates

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.

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.

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
We found this trial at
1
site
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials