Marijuana DependencePhase 2NCT00350649
Maximizing the Efficacy of Cognitive Behavior Therapy and Contingency Management
A Phase 2 study testing Standard CBT, CBT+CM/adherence and CM/abstinence in people with Marijuana Dependence, run by Yale University at 1 site in United States.
Trial summary
Cognitive-behavioral coping skills therapy (CBT) is a widely used and recognized treatment that has been empirically validated for a range of substance use disorders, often with emergent effects and continuing improvement even after treatment ends. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Marijuana Dependence
- What is being tested?
- Standard CBT, CBT+CM/adherence and CM/abstinence
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Sep 2010
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 year old marijuana dependent
- willing to sign consent
- no use of prescribed psychotropic drugs
- willing to give three individuals as contacts
- willing to accept randomization
- read and write English (third grade level)
Who cannot join
- unable to commit to 1 year follow up
Trial locations and contacts
1 site in 1 country.
About this study
Cognitive-behavioral coping skills therapy (CBT) is a widely used and recognized treatment that has been empirically validated for a range of substance use disorders, often with emergent effects and continuing improvement even after treatment ends. Treatment retention and compliance are associated with enhanced treatment outcomes in CBT. Contingency management (CM) also has very strong support and is associated with rapid, robust effects on targeted outcomes. Despite their many strengths, neither CBT nor CM is universally effective. It is now essential to seek strategies to maximize and extend the effectiveness of these two approaches and to better understand how these treatments exert their effects.
Read the detailed description
The investigators propose to evaluate targeted strategies to maximize the effectiveness of CBT and CM, respectively. To maximize the effectiveness of CBT, the investigators will evaluate the benefit of adding CM, with reinforcement for session attendance and homework completion, to standard individual CBT for outpatient marijuana abusers, in order to expose participants to more skill training and opportunities for practice of skills. To maximize the effectiveness and durability of CM, we will evaluate the benefit of integrating it with skills training, specifically designed to reduce drop off effects, in order to extend CM's benefits beyond the active treatment period. We propose to conduct a Stage II trial which will: (1) Evaluate the efficacy of four conditions for 160 marijuana dependent outpatients: (a) Standard CBT, (b) CBT with CM reinforcement for attendance and completing homework (CBT+CM/adherence), (c) CM for abstinence alone (CM/abstinence), (d) CM for abstinence integrated with CBT (CM/abstinence+CBT), and (2) Evaluate the longer-term durability and / or delayed emergence of treatment effects after termination of the study treatments through a one-year follow-up. Secondary aims will be to conduct (a) detailed process studies to evaluate whether the proposed enhancements affect proximal and distal outcomes as hypothesized and (b) economic analyses. Study treatments will last 12 weeks.
- Conditions
- Marijuana Dependence
- Being tested
- Standard CBT, CBT+CM/adherence, CM/abstinence, CM/abstinence+CBT
- Keywords
- behavior modification, cognitive behavioral therapy, combination therapy, drug abuse therapy, drug addition, human therapy evaluation, psychotherapy, clinical trial phase II, coping, drug and alcohol abstinence, longitudinal human study, outcomes research, outpatient care, psychological reinforcement, therapy compliance, behavior and social research tag, human subjects, neuropsychological test, patient oriented research
- Medical subject headings
- Marijuana Abuse, Alcohol Abstinence, Patient Compliance, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard CBTBehavioural
Manualized delivery of CBT by trained clinicians
CBT+CM/adherenceBehavioural
CBT and Clinical Management for attendance and completing homework
CM/abstinenceBehavioural
Contingency Management
CM/abstinence+CBTBehavioural
Contingency Management for abstinence in addition to manualized CBT delivered by a trained clinician
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | manualized delivery of CBT by trained clinicians Receives: Behavioral: Standard CBT |
| 2 | Active comparator | CBT with Contingency Management reinforcement for attendance and completing homework (CBT+CM/adherence) Receives: Behavioral: CBT+CM/adherence |
| 3 | Experimental | Contingency Management for abstinence alone (CM/abstinence) Receives: Behavioral: CM/abstinence |
| 4 | Active comparator | Contingency Management integrated with CBT (CM/abstinence+CBT) Receives: Behavioral: CM/abstinence+CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self reported marijuana use (days of abstinence by week) and results of urine toxicology screens
Measured: 12 weeks
Secondary outcomes (1)
Economic analysis with use of PACC-SAT
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2006 (estimated)
- Study startDec 2004
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marijuana 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
- Single group
- Masking
- None (open label)
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Kathleen Carroll, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00350649
- Sponsor's protocol ID
- 0407026913
- Status last verified
- Sep 2011
- First submitted
- 7 Jul 2006
- Last updated
- 27 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximizing the Efficacy of Cognitive Behavior Therapy and Contingency Management
- ClinicalTrials.gov ID
- NCT00350649
- Acronym / sponsor ID
- 0407026913
- Conditions
- Marijuana Dependence
- Keywords
- behavior modification, cognitive behavioral therapy, combination therapy, drug abuse therapy, drug addition, human therapy evaluation, psychotherapy, clinical trial phase II
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Dec 2004
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 11 Jul 2006 (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.
Cognitive-behavioral coping skills therapy (CBT) is a widely used and recognized treatment that has been empirically validated for a range of substance use disorders, often with emergent effects and continuing improvement even after treatment ends. Treatment retention and compliance are associated with enhanced treatment outcomes in CBT. Contingency management (CM) also has very strong support and is associated with rapid, robust effects on targeted outcomes. Despite their many strengths, neither CBT nor CM is universally effective. It is now essential to seek strategies to maximize and extend the effectiveness of these two approaches and to better understand how these treatments exert their effects.
Detailed description
The investigators propose to evaluate targeted strategies to maximize the effectiveness of CBT and CM, respectively. To maximize the effectiveness of CBT, the investigators will evaluate the benefit of adding CM, with reinforcement for session attendance and homework completion, to standard individual CBT for outpatient marijuana abusers, in order to expose participants to more skill training and opportunities for practice of skills. To maximize the effectiveness and durability of CM, we will evaluate the benefit of integrating it with skills training, specifically designed to reduce drop off effects, in order to extend CM's benefits beyond the active treatment period. We propose to conduct a Stage II trial which will: (1) Evaluate the efficacy of four conditions for 160 marijuana dependent outpatients: (a) Standard CBT, (b) CBT with CM reinforcement for attendance and completing homework (CBT+CM/adherence), (c) CM for abstinence alone (CM/abstinence), (d) CM for abstinence integrated with CBT (CM/abstinence+CBT), and (2) Evaluate the longer-term durability and / or delayed emergence of treatment effects after termination of the study treatments through a one-year follow-up. Secondary aims will be to conduct (a) detailed process studies to evaluate whether the proposed enhancements affect proximal and distal outcomes as hypothesized and (b) economic analyses. Study treatments will last 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Standard CBTmanualized delivery of CBT by trained clinicians |
| 2 | Active comparator | Behavioral: CBT+CM/adherenceCBT with Contingency Management reinforcement for attendance and completing homework (CBT+CM/adherence) |
| 3 | Experimental | Behavioral: CM/abstinenceContingency Management for abstinence alone (CM/abstinence) |
| 4 | Active comparator | Behavioral: CM/abstinence+CBTContingency Management integrated with CBT (CM/abstinence+CBT) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-65 year old marijuana dependent
- willing to sign consent
- no use of prescribed psychotropic drugs
- willing to give three individuals as contacts
- willing to accept randomization
Key exclusion criteria (1 listed)
- unable to commit to 1 year follow up
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 |
|---|---|---|
| Standard CBTManualized delivery of CBT by trained clinicians | Behavioural | 1 |
| CBT+CM/adherenceCBT and Clinical Management for attendance and completing homework | Behavioural | 2 |
| CM/abstinenceContingency Management | Behavioural | 3 |
| CM/abstinence+CBTContingency Management for abstinence in addition to manualized CBT delivered by a trained clinician | Behavioural | 4 |
Primary outcome
Self reported marijuana use (days of abstinence by week) and results of urine toxicology screens
Time frame: 12 weeks
1 secondary outcome
Economic analysis with use of PACC-SAT
Time frame: 12 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 27 Sep 2011.
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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.
Kathleen Carroll, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Standard CBT, CBT+CM/adherence and CM/abstinence in people with Marijuana Dependence, run by Yale University 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 1 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 27 Sep 2011. 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 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?
Self reported marijuana use (days of abstinence by week) and results of urine toxicology screens (time frame: 12 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 27 Sep 2011.