Cocaine Use DisordersPhase 1NCT00178776
A Transtheoretical Model Group Therapy for Cocaine
A Phase 1 study testing Transtheoretical Model Group Therapy and Education & Advice in people with Cocaine Use Disorders, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cocaine Use Disorders
- What is being tested?
- Transtheoretical Model Group Therapy and Education & Advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Jun 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion Criteria: Male and female adults (ages 18-65 years old), of any race, who meet DSM-IV criteria for cocaine abuse or dependence disorder will be recruited. In addition, eligible participants must be:
- (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.
Who cannot join
- 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;
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- (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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Houston Mental Sciences Institute
Houston, Texas, 77030
About this study
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.
Read the detailed description
Cocaine use in the general population is a significant and costly problem. Novel and innovative interventions targeting cocaine abuse are needed. The Transtheoretical Model of behavior change (TTM) offers a comprehensive framework for understanding, measuring, and intervening in behavior change and provides a strong theoretical foundation upon which effective treatments for substance abuse can be developed. The proposed Stage 1 research will pilot test a novel and innovative behavioral group therapy for cocaine users based on the TTM. In Phase 1, investigators will modify the newly developed Group Treatment for Substance Abuse: A Stages-of-Change Therapy Manual (Velasquez, Maurer, Crouch \& DiClemente, 2001) to specifically target cocaine abuse resulting in a twelve-session, group intervention and accompanying therapy manual based on the TTM stages and processes of change: six "early stage" sessions targeting the experiential processes of change, and six "later stage" sessions targeting the behavioral processes of change. Phase 2 will consist of a pilot trial to evaluate the TTM group therapy with cocaine abusing patients. A randomized, controlled, between groups design will be used in which cocaine abusers (N=80) are assigned to one of two group treatment conditions: TTM therapy or Education/Advice. Participants will be recruited from Houston and surrounding communities through the Substance Abuse Research Center at the University of Texas Health Science Center Mental Sciences Institute. We expect the delivery of the TTM therapy for cocaine users to be feasible and acceptable, and to produce significant patient improvement. Cocaine outcomes will be assessed via objective (urine and drug analysis) and self-report measures. This Stage I research will contribute important theoretical and empirical information concerning the promise of a new and innovative intervention for cocaine abusers, and will provide the basis for a larger efficacy trial.
- Conditions
- Cocaine Use Disorders
- Being tested
- Transtheoretical Model Group Therapy, Education & Advice
- Keywords
- Group, Therapy, Cocaine, Drugs, Trial, Outcome, Study, Feasibility, Transtheoretical, Stages, Motivation, Change
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transtheoretical Model Group TherapyBehavioural
Education & AdviceBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Transtheoretical Model Group | Experimental | Not described Receives: Behavioral: Transtheoretical Model Group Therapy |
| Education / Advice | Active comparator | Not described Receives: Behavioral: Education & Advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
4) Addiction Severity Index (ASI; Interviewer Administered)
5) Blood Alcohol Breath (biological)
6) Substance Use Report (self report)
Secondary Outcome Measures Related to Feasibility of the Group Therapy:
1) Participation / Attendance / Retention
2) MI Scale (Therapist Adherence)
3) Treatment Satisfaction Questionnaire
4) Group Therapy Alliance Scale
5) Group Atmosphere Scale
6) Therapist Treatment Evaluation
Secondary Outcome Measures Related to Psychiatric Symptoms:
1) Beck Depression Inventory (BDI-II)
2) Brief Symptom Inventory (BSI)
Secondary Outcomes Related to Functioning:
1) HIV Knowledge Questionnaire
2) Risk Behavior Assessment
3) SF-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startOct 2003
- Primary completionNov 2006
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cocaine Use DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, National Institute on Drug Abuse (NIDA)
- Investigators
- Mary Marden Velasquez, Ph.D., Principal investigator, University of Texas Houston Medical School, Dept. of Family & Community Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00178776
- Sponsor's protocol ID
- 5R01DA015453-02
- Other IDs
- R01DA015453-02, UT CPHS ID - HSC-MS-02-138
- Status last verified
- Sep 2014
- First submitted
- 13 Sep 2005
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Transtheoretical Model Group Therapy for Cocaine
- ClinicalTrials.gov ID
- NCT00178776
- Acronym / sponsor ID
- 5R01DA015453-02
- Conditions
- Cocaine Use Disorders
- Keywords
- Group, Therapy, Cocaine, Drugs, Trial, Outcome, Study, Feasibility
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Collaborators
- The University of Texas Health Science Center, Houston
- Study start
- Oct 2003
- Primary completion
- Nov 2006 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cocaine use in the general population is a significant and costly problem. Novel and innovative interventions targeting cocaine abuse are needed. The Transtheoretical Model of behavior change (TTM) offers a comprehensive framework for understanding, measuring, and intervening in behavior change and provides a strong theoretical foundation upon which effective treatments for substance abuse can be developed. The proposed Stage 1 research will pilot test a novel and innovative behavioral group therapy for cocaine users based on the TTM. In Phase 1, investigators will modify the newly developed Group Treatment for Substance Abuse: A Stages-of-Change Therapy Manual (Velasquez, Maurer, Crouch \& DiClemente, 2001) to specifically target cocaine abuse resulting in a twelve-session, group intervention and accompanying therapy manual based on the TTM stages and processes of change: six "early stage" sessions targeting the experiential processes of change, and six "later stage" sessions targeting the behavioral processes of change. Phase 2 will consist of a pilot trial to evaluate the TTM group therapy with cocaine abusing patients. A randomized, controlled, between groups design will be used in which cocaine abusers (N=80) are assigned to one of two group treatment conditions: TTM therapy or Education/Advice. Participants will be recruited from Houston and surrounding communities through the Substance Abuse Research Center at the University of Texas Health Science Center Mental Sciences Institute. We expect the delivery of the TTM therapy for cocaine users to be feasible and acceptable, and to produce significant patient improvement. Cocaine outcomes will be assessed via objective (urine and drug analysis) and self-report measures. This Stage I research will contribute important theoretical and empirical information concerning the promise of a new and innovative intervention for cocaine abusers, and will provide the basis for a larger efficacy trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transtheoretical Model Group | Experimental | Behavioral: Transtheoretical Model Group Therapy |
| Education / Advice | Active comparator | Behavioral: Education & Advice |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Inclusion Criteria: Male and female adults (ages 18-65 years old), of any race, who meet DSM-IV criteria for cocaine abuse or dependence disorder will be recruited. In addition, eligible participants must be:
- (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.
Key exclusion criteria (9 listed)
- (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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transtheoretical Model Group Therapy | Behavioural | Transtheoretical Model Group |
| Education & Advice | Behavioural | Education / Advice |
Primary outcome
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.
22 secondary outcomes
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)
4) Addiction Severity Index (ASI; Interviewer Administered)
5) Blood Alcohol Breath (biological)
6) Substance Use Report (self report)
Secondary Outcome Measures Related to Feasibility of the Group Therapy:
1) Participation / Attendance / Retention
2) MI Scale (Therapist Adherence)
3) Treatment Satisfaction Questionnaire
4) Group Therapy Alliance Scale
5) Group Atmosphere Scale
6) Therapist Treatment Evaluation
Secondary Outcome Measures Related to Psychiatric Symptoms:
1) Beck Depression Inventory (BDI-II)
2) Brief Symptom Inventory (BSI)
Secondary Outcomes Related to Functioning:
1) HIV Knowledge Questionnaire
2) Risk Behavior Assessment
3) SF-12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
- BackgroundVelasquez, 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Marden Velasquez, Ph.D. principal investigator
University of Texas Houston Medical School, Dept. of Family & Community Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Transtheoretical Model Group Therapy and Education & Advice in people with Cocaine Use Disorders, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00178776, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2017.