NCT00227812

Brief Summary

The purpose of this study is to test whether cognitive behavioral therapy and bupropion hydrochloride will help cocaine users, who are depressed, reduce or end their cocaine use and improve their mood.

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 Apr 2001

Longer than P75 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

April 1, 2001

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

January 12, 2017

Status Verified

January 1, 2009

Enrollment Period

4.7 years

First QC Date

September 27, 2005

Last Update Submit

January 11, 2017

Conditions

Cocaine DependenceDepressive Disorder, Major

Keywords

cocaine dependence

Outcome Measures

Primary Outcomes (1)

  • Urine toxicology for cocaine

Interventions

BupropionDRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Generally physically healthy
  • Aged 18-55
  • Meets cocaine dependence by DSM-IV criteria
  • Meets major depressive disorder or substance-induced depression disorder by DSM-IV criteria.
  • Willing and able to participate in the 12 week treatment study and one year follow up.

You may not qualify if:

  • Pregnant or breastfeeding.
  • Taking medications that interact with the study medication (MAO inhibitors, anticonvulsants, haloperidol, phenothiazines,selegiline, anesthetics
  • Have other psychiatric diagnoses requiring therapy or medication.
  • Physically dependent on opiates or alcohol.
  • Currently being treated with bupropion hydrochloride (e.g. Zyban).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Sci Cntr Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Cocaine-Related DisordersDepressive Disorder, Major

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersDepressive DisorderMood Disorders

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic Chemicals

Study Officials

  • Joy Schmitz, Ph.D.

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

September 27, 2005

First Posted

September 28, 2005

Study Start

April 1, 2001

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

January 12, 2017

Record last verified: 2009-01

Locations

US(1)