Buprenorphine Dosing Interval - 5

Opioid-Related Disorders Clinical Trial

Official title:

Buprenorphine Dosing Interval

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000209
• Other study ID #: NIDA-06082-5
• Secondary ID: R18-06082-5
• Status: Completed
• Phase: Phase 2
• First received: September 20, 1999
• Last updated: August 16, 2005
• Start date: November 1992

Study information

• Verified date: September 1994
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to explore the feasibility of extending the dosing interval of well maintained buprenorphine patients to 48 and 72 hours, leading to eventual 3 times/week dosing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 50 Years

Eligibility

Inclusion Criteria:

M/F ages 21-50. Opiate dependence according to DSM-IV critera. Self-reported use within the last 30 days. Agreeable to conditions of study and signed informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nursing women. Dependence on ETOH or benzodiazepines or other sedative-hynotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.

Study Design

Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opioid-Related Disorders

Intervention

Drug:
• Buprenorphine

Locations

Country	Name	City	State
United States	Friends Research Institute	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

1) Buprenorphine as a pharmacotherapy for opiate addiction. What dose provides a therapeutic response? (An J Add 1996; 5(3): 220-222). (1) Buprenorphine as a pharmacotherapy for opiate addiction. What dose provides a therapeutic response? (An J Add 1996; 5(3):220-222).

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drug use
Primary	Withdrawal symptoms
Primary	Opiate and cocaine craving