Rapid Opiate Detoxification and Naltrexone Induction Using Buprenorphine - 2

Rapid Opiate Detoxification & Naltrexone Induction Using Bup.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00000299

Enrollment

Registered

1999-09-21

Start date

2008-10-31

Completion date

2009-11-30

Last updated

2016-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid-Related Disorders

Keywords

Opioid-Related Disorders

Brief summary

The purpose of this study is to develop a clinical protocol to detoxify patients from opiates to naltrexone using buprenorphine and to develop pilot data for a grant application for a controlled study of the efficacy of the new clinical protocol for outpatients.

Interventions

DRUGBuprenorphine

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

21 Years to 50 Years

Healthy volunteers

Inclusion criteria

Males/Females, ages 21-50. Opiate dependence according to DSM-IV criteria. 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. Dependent on etoh or benzodiazepines or other sedative-hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.

Design outcomes

Primary

Measure	Time frame	Description
Opiate craving	10 test days	opiate craving is measured on each test day.
Opiate withdrawal symptoms	10 test days	opiate withdrawal symptoms are documented for each test day

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026