NCT00178776

Brief Summary

The purpose of this study is to determine the feasibility and promise of a recently manualized group therapy based on the Transtheoretical Model for cocaine use disorders.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
138

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2003

Typical duration for phase_1

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, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

January 11, 2017

Status Verified

September 1, 2014

Enrollment Period

3.1 years

First QC Date

September 13, 2005

Last Update Submit

January 10, 2017

Conditions

Cocaine Use Disorders

Keywords

GroupTherapyCocaineDrugsTrialOutcomeStudyFeasibilityTranstheoreticalStagesMotivationChange

Outcome Measures

Primary Outcomes (1)

  • Urinalysis indicating presence or absence of cocaine metabolites, used to calculate percent days abstinent, collected at intake, once weekly during the 6 week group treatment phase, at post-treatment, and 3 months.

Secondary Outcomes (22)

  • Secondary Outcome Measures Related to Cocaine and other Drug Use:

  • 1) Timeline Follow-Back (self-reported use / percent days

  • abstinent)

  • 2) Cocaine Craving Worksheet (self report)

  • 3) Cocaine Negative Consequences Checklist (self report)

  • +17 more secondary outcomes

Study Arms (2)

Transtheoretical Model Group

EXPERIMENTAL
Behavioral: Transtheoretical Model Group Therapy

Education / Advice

ACTIVE COMPARATOR
Behavioral: Education & Advice

Interventions

Transtheoretical Model Group TherapyBEHAVIORAL
Transtheoretical Model Group
Education & AdviceBEHAVIORAL
Education / Advice

Eligibility Criteria

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

You may qualify if:

  • (1) judged to be in generally good physical and psychiatric health except for possible acute drug related problems;
  • (2) willing and able to participate in the 6-week, group outpatient treatment;
  • (3) able to provide the name of at least one person who can generally locate their whereabouts; and
  • (4) willing to be followed for 3 months after treatment ends.
  • Potential subjects with simple drug charges whose legal contacts are willing to forego data revelation will be included. Although cocaine dependence will be the primary drug for which patients are seeking treatment, we will not exclude participants who are abusing additional substances.

You may not qualify if:

  • Individuals will be ineligible for study participation based on the following criteria:
  • (1) current diagnosis of an Axis I psychiatric disorder other than cocaine dependence;
  • (2) current psychiatric symptoms requiring medication;
  • (3) severe medical, cognitive and /or psychiatric impairment that precludes cooperation with study protocol;
  • (4) substance withdrawal symptoms requiring medical attention;
  • (5) currently receiving other psychosocial therapy for substance abuse with the exception of AA, NA or CA;
  • (6) impending incarceration;
  • (7) inability to read, write, speak English;
  • (8) inability or unwillingness to participate in the 6-week, group outpatient treatment (e.g., halfway house or other aftercare program restrictions).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Houston Mental Sciences Institute

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Velasquez, M. M., Maurer, G. G., Crouch, C., & DiClemente, C. C. (2001). Group treatment for substance abuse: A stages-of-change therapy manual. New York: Guilford Press.

    BACKGROUND

MeSH Terms

Interventions

Educational StatusCounseling

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation CharacteristicsMental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Mary Marden Velasquez, Ph.D.

    University of Texas Houston Medical School, Dept. of Family & Community Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

October 1, 2003

Primary Completion

November 1, 2006

Study Completion

June 1, 2007

Last Updated

January 11, 2017

Record last verified: 2014-09

Locations

US(1)