NCT00000326

Brief Summary

The purpose of this study is to assess the clinical efficacy of the buprenorphine/naloxone combination tablet for alternate-day dosing and determine whether multiples of the daily dose are necessary to maintain an effective alternate day dosing regimen.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 1997

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1997

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 1997

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 1997

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 20, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 1999

Completed
Last Updated

May 4, 2017

Status Verified

May 1, 2017

Enrollment Period

4 months

First QC Date

September 20, 1999

Last Update Submit

May 2, 2017

Conditions

Heroin DependenceOpioid-Related Disorders

Keywords

Heroin Dependence

Outcome Measures

Primary Outcomes (12)

  • Drug use

  • Retention

  • Subjective dose estimate

  • Observed withdrawal rating

  • Opioid agonist rating

  • Opioid antagonist rating

  • Pupil diameter

  • Compliance

  • Analog rating scale for drug effects

  • Drug effect characteristics

  • Dose order estimate-nurse

  • Dose order estimate-client

Interventions

Heroin DependenceDRUG

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals must be 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.

You may not qualify if:

  • Individuals with evidence of an 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Health Sciences Center

Denver, Colorado, 80206, United States

Location

Related Publications (1)

  • (presented at ACNP 1997. Kamien, J.B., Mikulich, S.K., and Amass, L., Efficacy of the buprenorphine/naloxone tablet for daily vs. alternate-day opioid dependence treatment. Presented to the 1998 Meeting of the College on Problems of Drug Dependence.. Presented at ACNP 1997 and CPDD 1998.

    BACKGROUND

MeSH Terms

Conditions

Heroin DependenceOpioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Leslie Amass, Ph.D.

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 1999

First Posted

September 21, 1999

Study Start

April 1, 1997

Primary Completion

August 1, 1997

Study Completion

August 1, 1997

Last Updated

May 4, 2017

Record last verified: 2017-05

Locations

US(1)