NCT00000200

Brief Summary

The purpose of this study is to compare the effects of buprenorphine or methadone maintenance on cocaine taking and on the physiological and subjective effects of cocaine, including cocaine craving, in opiate-dependent cocaine users.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 1997

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

January 1, 1997

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 1998

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 1998

Completed
1.7 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

January 12, 2017

Status Verified

October 1, 2016

Enrollment Period

1 year

First QC Date

September 20, 1999

Last Update Submit

January 11, 2017

Conditions

Cocaine-Related Disorders

Keywords

self-administration

Outcome Measures

Primary Outcomes (3)

  • Interaction of cocaine and meds on cardio

    3 hr

  • Interaction of cocaine & meds on coc's subjective

    3 hr

  • Effects of medication on cocaine craving

    3 hr

Interventions

MethadoneDRUG

normal maintenance dose

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Please contact site for information.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Columbia University

New York, New York, 10023, United States

Location

Related Publications (1)

  • Foltin RW, Fischman MW. Effects of methadone or buprenorphine maintenance on the subjective and reinforcing effects of intravenous cocaine in humans. J Pharmacol Exp Ther. 1996 Sep;278(3):1153-64.

    PMID: 8819498RESULT

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Methadone

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

KetonesOrganic Chemicals

Study Officials

  • Marian Fischman, Ph.D.

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

September 20, 1999

First Posted

September 21, 1999

Study Start

January 1, 1997

Primary Completion

January 1, 1998

Study Completion

January 1, 1998

Last Updated

January 12, 2017

Record last verified: 2016-10

Locations

US(1)