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Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-1 - 4

Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-1

Status
Withdrawn
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00000329
Enrollment
0
Registered
1999-09-21
Start date
1999-04-30
Completion date
1999-08-31
Last updated
2017-05-04

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

Conditions

Heroin Dependence, Opioid-Related Disorders

Keywords

drug dependence

Brief summary

The purpose of this study is to assess the abuse liability and examine the reinforcing effects of intravenous buprenorphine and buprenorphine/naloxone combinations in buprenorphine-naloxone maintained volunteers

Detailed description

Ongoing study - results not available at this time

Interventions

DRUGOpioid-Related Disorders

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
University of Colorado, Denver
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

Individuals must be at least 18 yrs of age, currently opioid dependent and meet FDA criteria for narcotic maintenance treatment. Co-morbid substance abuse or dependence disorders may also be present. Individuals must be healthy despite drug dependency and have a history of IV opioid use.

Exclusion criteria

Individuals with evidence of anti active Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I psychiatric disorder (e.g. psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g. liver or cardiovascular disease) or pregnant female subjects are excluded from study participation.

Design outcomes

Primary

MeasureTime frame
Subjective dose estimate
Observed withdrawal rating
Opioid agonist rating
Opioid antagonist rating
Pupil diameter
Analog rating scale for drug effects
Drug effect characteristics
Drug/Money Preferences

Countries

United States

Outcome results

None listed

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