NCT00000320

Brief Summary

The purpose of this study is to compare subject response to liquid vs. tablet formulations, to assess bioequivalency of liquid vs. tablet, to compare subject preference, and to evaluate if dose response curve for tablet is equal to liquid form."

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 1997

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

October 1, 1997

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 1999

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 1999

Completed
2 months 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

January 12, 2017

Status Verified

January 1, 2009

Enrollment Period

1.8 years

First QC Date

September 20, 1999

Last Update Submit

January 11, 2017

Conditions

Opioid-Related Disorders

Keywords

opioid dependence

Outcome Measures

Primary Outcomes (1)

  • blood level

    across study duration

Secondary Outcomes (3)

  • drug use

    across study duration

  • craving

    across study duration

  • withdrawal symptoms

    across study duration

Study Arms (2)

1; liquid formulation

ACTIVE COMPARATOR

liquid formulation

Drug: Buprenorphine formulation: liquid vs. tablet

2; tablet formulation

ACTIVE COMPARATOR

tablet formulation

Drug: Buprenorphine formulation: liquid vs. tablet

Interventions

Buprenorphine formulation: liquid vs. tabletDRUG

random assignment to liquid buprenorphine or tablet buprenorphine

Also known as: Subutex, Suboxone
1; liquid formulation2; tablet formulation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • M/F ages 18-65. Meet DMS-IV criteria for opiate dependence. Agree to conditions of the study and sign informed consent.

You may not qualify if:

  • Pregnant or nursing women. Acute medical condition that would interfere with study participation or put safety of subjects in jeopardy. Current daily use of anti-convulsants, antabuse or neuroleptics. DSM-IV diagnosis of ETOH or sedative/hypnotics dependence.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Friends Research Institute

Los Angeles, California, 90025, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

BuprenorphineBuprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsNaloxoneDrug CombinationsPharmaceutical Preparations

Study Officials

  • Walter Ling, M.D.

    Friends Research Institute, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

September 20, 1999

First Posted

September 21, 1999

Study Start

October 1, 1997

Primary Completion

August 1, 1999

Study Completion

August 1, 1999

Last Updated

January 12, 2017

Record last verified: 2009-01

Locations

US(1)