Cocaine DependencePhase 2NCT00914381
Behavioral Treatment for Cocaine Dependent Women
A Phase 2 study testing Behavioral therapy in people with Cocaine Dependence, run by Yale University at 2 sites in United States.
Trial summary
To compare the efficacy of Community Reinforcement Approach (CRA) and 12-Step Facilitation (TSF) counseling and of voucher based reward therapy (VBRT) and a yoked, non-contingent voucher control (VC) for the treatment of cocaine dependent pregnant women or women with young children. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Cocaine Dependence
- What is being tested?
- Behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 1994to Mar 2002
- Phase
- Phase 2
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women meeting DSM IV criteria for cocaine dependence
- Women meeting DSM IV criteria for cocaine dependence with custody of a young child
Who cannot join
- Opioid dependence
- Psychosis
- Severe depression
- Current treatment with any anti-depressant or anti-psychotic medication
- Medical instability
- Inability to understand or read English
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The APT Foundation, Inc. MRU
New Haven, Connecticut, 06519
Yale University School of Medicine
New Haven, Connecticut, 06519
About this study
To compare the efficacy of Community Reinforcement Approach (CRA) and 12-Step Facilitation (TSF) counseling and of voucher based reward therapy (VBRT) and a yoked, non-contingent voucher control (VC) for the treatment of cocaine dependent pregnant women or women with young children.
Read the detailed description
Subjects were randomly assigned to 1 of 4 treatment groups (CRA+VBRT, CRA+VC, TSF+VBRT, TSF+VC). VBRT voucher value increased for each successive cocaine-free urine sample obtained twice weekly during the 1st 12 weeks and was faded from the final earned value to $5 during the last 12 weeks. All subjects earned vouchers for attendance at scheduled twice weekly counseling sessions. Manual-guided CRA and TSF were provided by experienced clinicians.
- Conditions
- Cocaine Dependence
- Being tested
- Behavioral therapy
- Keywords
- Community reinforcement approach, Contingency management, 12-step facilitation counseling, Cocaine dependence, Women
- Medical subject headings
- Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral therapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| CRA + CM | Active comparator | Community Reinforcement Approach (CRA) combined with Contingency Management (CM) Receives: Behavioral: Behavioral therapy |
| TSF + CM | Active comparator | Twelve-Step Facilitation (TSF) combined with Contingency Management (CM) Receives: Behavioral: Behavioral therapy |
| CRA + VC | Active comparator | Community Reinforcement Approach (CRA) combined with Voucher Control (VC) Receives: Behavioral: Behavioral therapy |
| TSF + VC | Active comparator | Twelve-Step Facilitation (TSF) combined with Voucher Control (VC) Receives: Behavioral: Behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cocaine abstinence
Measured: 24 weeks
Secondary outcomes (1)
Reduced HIV risk behavior
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2009 (estimated)
- Study startDec 1994
- Primary completionMar 2002
- Study completionMar 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine DependenceStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Investigators
- Richard S. Schottenfeld, M.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00914381
- Sponsor's protocol ID
- 9410007875
- Other IDs
- R01DA006915
- Status last verified
- Jun 2009
- First submitted
- 3 Jun 2009
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Treatment for Cocaine Dependent Women
- ClinicalTrials.gov ID
- NCT00914381
- Acronym / sponsor ID
- 9410007875
- Conditions
- Cocaine Dependence
- Keywords
- Community reinforcement approach, Contingency management, 12-step facilitation counseling, Cocaine dependence, Women
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Dec 1994
- Primary completion
- Mar 2002 (actual)
- Study completion
- Mar 2002 (actual)
- First posted
- 5 Jun 2009 (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.
To compare the efficacy of Community Reinforcement Approach (CRA) and 12-Step Facilitation (TSF) counseling and of voucher based reward therapy (VBRT) and a yoked, non-contingent voucher control (VC) for the treatment of cocaine dependent pregnant women or women with young children.
Detailed description
Subjects were randomly assigned to 1 of 4 treatment groups (CRA+VBRT, CRA+VC, TSF+VBRT, TSF+VC). VBRT voucher value increased for each successive cocaine-free urine sample obtained twice weekly during the 1st 12 weeks and was faded from the final earned value to $5 during the last 12 weeks. All subjects earned vouchers for attendance at scheduled twice weekly counseling sessions. Manual-guided CRA and TSF were provided by experienced clinicians.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CRA + CM | Active comparator | Behavioral: Behavioral therapyCommunity Reinforcement Approach (CRA) combined with Contingency Management (CM) |
| TSF + CM | Active comparator | Behavioral: Behavioral therapyTwelve-Step Facilitation (TSF) combined with Contingency Management (CM) |
| CRA + VC | Active comparator | Behavioral: Behavioral therapyCommunity Reinforcement Approach (CRA) combined with Voucher Control (VC) |
| TSF + VC | Active comparator | Behavioral: Behavioral therapyTwelve-Step Facilitation (TSF) combined with Voucher Control (VC) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pregnant women meeting DSM IV criteria for cocaine dependence
- Women meeting DSM IV criteria for cocaine dependence with custody of a young child
Key exclusion criteria (6 listed)
- Opioid dependence
- Psychosis
- Severe depression
- Current treatment with any anti-depressant or anti-psychotic medication
- Medical instability
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 |
|---|---|---|
| Behavioral therapy | Behavioural | CRA + CM, CRA + VC, TSF + CM, TSF + VC |
Primary outcome
Cocaine abstinence
Time frame: 24 weeks
1 secondary outcome
Reduced HIV risk behavior
Time frame: 24 weeks
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 31 Mar 2020.
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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.
Richard S. Schottenfeld, M.D. principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Behavioral therapy in people with Cocaine Dependence, run by Yale University at 2 sites 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 2 inclusion and 6 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 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Cocaine abstinence (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2020.