NCT00033111

Brief Summary

The purpose of this study is to assess cabergoline for the Treatment of Cocaine Dependence

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2001

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

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

June 1, 2001

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 8, 2002

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
Last Updated

January 12, 2017

Status Verified

October 1, 2016

First QC Date

April 5, 2002

Last Update Submit

January 11, 2017

Conditions

Cocaine-Related DisordersSubstance-Related Disorders

Outcome Measures

Primary Outcomes (1)

  • To assess the efficacy of cabergoline in reducing cocaine use in subjects with cocaine dependence

    Success in the reduction of cocaine use was determined by comparing cocaine non-use days (self-report confirmed or disproved by urine BE level at each study visit) expressed as the weekly mean proportion of non-use days to the total number of non-missing study days that week.

    Week 12

Secondary Outcomes (1)

  • Reduction in cocaine use

    12 weeks

Study Arms (2)

Cabergoline

ACTIVE COMPARATOR

Subjects received one tablet of 0.5 mg of cabergoline tablet per week for 12 weeks.

Drug: Cabergoline

Placebo

PLACEBO COMPARATOR

Subjects received one tablet of 0.5 mg of cabergoline matched placebo tablet per week for 12 weeks.

Drug: Placebo

Interventions

CabergolineDRUG
Also known as: Dostinex
Cabergoline
PlaceboDRUG

sugar pill manufactured to mimic cabergoline 05mg tablet

Placebo

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must have a DSM-4 criteria for cocaine dependence; be seeking treatment for cocaine dependence; have the ability to understand and provide written informed consent; females of child-bearing potential using proper method of birth control.

You may not qualify if:

  • Additional criteria available during screening at the site.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Torrance Clinic

Torrance, California, 90502, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Cocaine-Related DisordersSubstance-Related Disorders

Interventions

Cabergoline

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ErgolinesErgot AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-Ring

Study Officials

  • Steve Shoptaw, Ph.D.

    Friends Research Institute, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2002

First Posted

April 8, 2002

Study Start

June 1, 2001

Study Completion

April 1, 2004

Last Updated

January 12, 2017

Record last verified: 2016-10

Locations

US(2)