NCT00015028

Brief Summary

The purpose of this study is to determine the efficacy and safety of a buprenorphine/naloxone sublingual tablet formulation as an office-based therapy for opiate-dependence treatment. The developmental objective for this combination product is an expansion of therapeutic options for the treatment of opiate dependence.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Nov 1996

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 1996

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 1996

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 1997

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2001

Completed
Same day until next milestone

First Posted

Study publicly available on registry

April 18, 2001

Completed
Last Updated

January 16, 2017

Status Verified

November 1, 1996

Enrollment Period

1 month

First QC Date

April 18, 2001

Last Update Submit

January 13, 2017

Conditions

Opioid-Related DisordersSubstance-Related Disorders

Keywords

opioid dependence

Outcome Measures

Primary Outcomes (5)

  • Craving

  • Drug use

  • HIV risk behaviors

  • Adverse events

  • Medical evaluation

Interventions

Buprenorphine/naloxoneDRUG

Eligibility Criteria

Age23 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • DSM-IV (Diagnostic and Statistical Manual of the American Psychiatric Association) diagnosis of current opiate dependence.
  • Individuals seeking opiate-substitution pharmacotherapy for opiate dependence.
  • Males and non-pregnant, non-nursing females, 18 to 59 years of age (inclusive).
  • Individuals able to give informed consent and willing to comply with all study procedures (e.g., providing of urine samples under observation, completing questionnaires).

You may not qualify if:

  • Any acute or chronic medical condition that would make participation in the study medically hazardous (e.g., acute hepatitis, unstable cardiovascular, hepatic, or renal disease, unstable diabetes, symptomatic AIDS; not HIV-seropositivity alone).
  • Aspartate or alanine aminotransferase (AST, ALT) levels greater than three times the upper limit of normal.
  • Individuals currently taking systemic anti-retroviral or anti-fungal therapy.
  • Current dependence (by DSM-IV criteria) on any psychoactive substance other than opiates, caffeine, or nicotine.
  • Current, primary, Axis I psychiatric diagnosis other than opiate, caffeine, or nicotine dependence.
  • Females of childbearing potential who do not agree to use a medically acceptable method of birth control. Acceptable methods include
  • oral contraceptive,
  • barrier (diaphragm or condom) - a spermicide is not required due to the possibility of local irritation and allergic type reactions, but are recommended for use,
  • levonorgestrel implant,
  • intrauterine progesterone contraceptive system,
  • medroxyprogesterone acetate contraceptive injection, or
  • complete abstinence.
  • Enrollment in an opiate-substitution (i.e., methadone, levo-alpha-acetylmethadol) treatment program within 45 days of enrolling in the present study.
  • Individuals having taken (licitly or illicitly) LAAM, methadone, or naltrexone within days of enrolling in the present study.
  • Individuals having taken buprenorphine, other than as an analgesic, within 365 days of enrolling in the present study.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati MDRU

Cincinnati, Ohio, 45220, United States

Location

MeSH Terms

Conditions

Opioid-Related DisordersSubstance-Related Disorders

Interventions

Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BuprenorphineMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsNaloxoneHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Eugene Somoza, M.D., Ph.D.

    Cincinnati MDRU

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

April 18, 2001

First Posted

April 18, 2001

Study Start

November 1, 1996

Primary Completion

December 1, 1996

Study Completion

January 1, 1997

Last Updated

January 16, 2017

Record last verified: 1996-11

Locations

US(1)