Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00326235
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2006-05-12
Brief Title:
Effects of Buspirone in Opiate Withdrawal
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
Effects of Buspirone in Withdrawal From Opiates
Status:
COMPLETED
Status Verified Date:
2005-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None