Marijuana DependenceMTP4NCT02030665
Marijuana Treatment Project 4
A study testing Contingency Management, Individualized Assessment & Treatment and Cognitive-Behavioral Treatment in people with Marijuana Dependence, run by UConn Health at 1 site in United States.
Trial summary
Marijuana is the most commonly used illicit drug in the US, but treatment for marijuana dependence is not fully effective. In the current proposal we are exploring the idea that more tailored teaching of coping skills may result in improved outcomes for marijuana-dependence than those seen thus far. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Marijuana Dependence
- What is being tested?
- Contingency Management, Individualized Assessment & Treatment and Cognitive-Behavioral Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Apr 2018
- Phase
- Interventional
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- at least 18 yrs old
- meet Diagnostic and Statistical Manual IV (DSM-IV) criteria for Cannabis Dependence
- be willing to accept random assignment to any of the 4 treatment conditions
Who cannot join
- acute medical/psychiatric problems that require inpatient treatment (e.g., acute psychosis, severe depression, suicide/homicide risk)
- reading ability below the fifth grade level
- lack of reliable transportation
- excessive commuting distance.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut Health Center
Farmington, Connecticut, 06030
About this study
Official title: Individualized Assessment and Treatment for Marijuana Dependence: Treatment Mechanisms
Marijuana is the most commonly used illicit drug in the US, but treatment for marijuana dependence is not fully effective. In the current proposal we are exploring the idea that more tailored teaching of coping skills may result in improved outcomes for marijuana-dependence than those seen thus far. Participants will be 275 men and women meeting criteria for marijuana dependence and randomly assigned to 9 sessions of treatment in one of 4 treatment conditions: Standardized MET plus CB (SMET-CB); SMET+ CM (SMET-CB-CM); IATP; or IATP + CM (IATP-CM). Patients in all treatments will engage in ES via cell-phone for two weeks prior to treatment, for a weekly period during treatment, for another week after treatment has ended, and for two weekly periods at months 8 and 14. In the IATP conditions, the information gathered from the pretreatment and during-treatment ES periods will provide data for a functional analysis of patients' drug use and urges to use. It is hypothesized that IATP conditions will yield significantly better coping skills acquisition than SMET-CB conditions, both at posttreatment and at extended follow-ups, and that change in coping skills will predict better outcomes for the IATP conditions
Read the detailed description
Marijuana is the most commonly used illicit drug in the US, but treatment for marijuana dependence is not fully effective. The most effective treatments to date have employed motivational enhancement (MET) plus cognitive-behavioral coping skills treatment (CB) and contingency management (CM) for abstinence. This proposal is a competitive renewal of our recently completed study to enhance coping and self-efficacy to improve marijuana outcomes in the long term. In the current proposal we are exploring the idea that more tailored teaching of coping skills may result in improved outcomes for marijuana-dependence than those seen thus far. The Individualized Assessment and Treatment Program (IATP) for marijuana dependent patients will employ experience sampling (ES) to determine the strengths and weaknesses of each patient in drug-use situations so that treatment can be tailored accordingly. Results from a pilot study indicated that IATP for alcohol dependent patients yielded better drinking outcomes at posttreatment than a packaged CB program (PCBT), that IATP patients reported greater use of coping skills than PCBT participants, and that posttreatment reports of coping skills were related to posttreatment drinking. Participants will be 275 men and women meeting criteria for marijuana dependence and randomly assigned to 9 sessions of treatment in one of 4 treatment conditions: Standardized MET plus CB (SMET-CB); SMET+ CM (SMET-CB-CM); IATP; or IATP + CM (IATP-CM). Patients in all treatments will engage in ES via cell-phone for two weeks prior to treatment, for a weekly period during treatment, for another week after treatment has ended, and for two weekly periods at months 8 and 14. In the IATP conditions, the information gathered from the pretreatment and during-treatment ES periods will provide data for a functional analysis of patients' drug use and urges to use. Therapists will use the information to address specific cognitions, affects, and behaviors that are adaptive and maladaptive, and will tailor a specific coping skills program with the patient. During-treatment experience sampling will allow adjustment of the treatment goals and procedures, making the treatment adaptive. In the SMET-CB conditions the experience sampling data will not be used in therapy, but will still provide in-vivo measures of drinking and coping skills. It is hypothesized that IATP conditions will yield significantly better coping skills acquisition than SMET-CB conditions, both at posttreatment and at extended follow-ups, and that change in coping skills will predict better outcomes for the IATP conditions. It is further predicted that the addition of CM to both IATP and SMET-CB will enhance short-term and long-term outcomes. The results will have implications for improved tailoring of treatment to patients' strength and deficits, and for the validity of the training of coping skills for relapse prevention. The data collected will shed light on the ways in which patients in treatment use coping skills in real-time contexts. Finally, the use of repeated ES periods will allow us to determine how treatment impacts thoughts, feelings and behaviors, and how these in turn affect outcome in the long and short term.
- Conditions
- Marijuana Dependence
- Being tested
- Contingency Management, Individualized Assessment & Treatment, Cognitive-Behavioral Treatment
- Keywords
- Marijuana Dependence, Individualized treatment, Motivational Enhancement Treatment, Cognitive-Behavioral Treatment, Contingency Management
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency ManagementBehavioural
Also called Positive Reinforcement
Reinforcement provided contingent upon demonstration of negative drug tests
Individualized Assessment & TreatmentBehavioural
Also called IATP
Tailored Cognitive-Behavioral Treatment based on detailed records of patient behavior
Cognitive-Behavioral TreatmentBehavioural
Also called CBT
Standard psychoeducational approach to coping skills training
| Study group | Role | What they receive |
|---|---|---|
| Standardized MET plus CB (SMET-CB) | Active comparator | Motivational Enhancement plus Cognitive-Behavioral treatment Receives: Behavioral: Cognitive-Behavioral Treatment |
| SMET+ CM (SMET-CB-CM) | Experimental | Motivational Enhancement plus CB treatment plus contingency management Receives: Behavioral: Contingency Management |
| Individualized Assessment & Treatment (IATP) | Experimental | Individualized Assessment and Treatment Program; Cognitive-Behavioral Treatment based on in-depth field monitoring of patient behavior Receives: Behavioral: Individualized Assessment & Treatment |
| IATP + CM (IATP-CM). | Experimental | Individualized Assessment and Treatment plus Contingency Management Receives: Behavioral: Contingency Management; Behavioral: Individualized Assessment & Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marijuana Use
Marijuana use measured in terms of Days of use in every 90-day period
Measured: every 3 months
Secondary outcomes (1)
Coping Skills
Coping Skills measured using the Coping Skills Survey, administered every 3 months
Measured: every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startFeb 2013
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Marijuana DependenceStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Mark Litt, UConn Health
- Investigators
- Mark D Litt, PhD, Principal investigator, UConn HealthElise Kabela-Cormier, PhD, Study director, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02030665
- Sponsor's protocol ID
- 12-174-3
- Other IDs
- R01DA012728
- Acronym
- MTP4
- Status last verified
- Jun 2019
- First submitted
- 7 Jan 2014
- Last updated
- 21 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Litt MD, Kadden RM, Tennen H, Dunn HK. Momentary coping and marijuana use in treated adults: Exploring mechanisms of treatment. J Consult Clin Psychol. 2021 Apr;89(4):264-276. doi: 10.1037/ccp0000633.
PubMed 34014689Litt MD, Kadden RM, Tennen H, Petry NM. Individualized assessment and treatment program (IATP) for cannabis use disorder: Randomized controlled trial with and without contingency management. Psychol Addict Behav. 2020 Feb;34(1):40-51. doi: 10.1037/adb0000491. Epub 2019 Jul 18.
PubMed 31318225
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Assessment and Treatment for Marijuana Dependence: Treatment Mechanisms
- ClinicalTrials.gov ID
- NCT02030665
- Acronym / sponsor ID
- MTP4 / 12-174-3
- Conditions
- Marijuana Dependence
- Keywords
- Marijuana Dependence, Individualized treatment, Motivational Enhancement Treatment, Cognitive-Behavioral Treatment, Contingency Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Feb 2013
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 8 Jan 2014 (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.
Marijuana is the most commonly used illicit drug in the US, but treatment for marijuana dependence is not fully effective. In the current proposal we are exploring the idea that more tailored teaching of coping skills may result in improved outcomes for marijuana-dependence than those seen thus far. Participants will be 275 men and women meeting criteria for marijuana dependence and randomly assigned to 9 sessions of treatment in one of 4 treatment conditions: Standardized MET plus CB (SMET-CB); SMET+ CM (SMET-CB-CM); IATP; or IATP + CM (IATP-CM). Patients in all treatments will engage in ES via cell-phone for two weeks prior to treatment, for a weekly period during treatment, for another week after treatment has ended, and for two weekly periods at months 8 and 14. In the IATP conditions, the information gathered from the pretreatment and during-treatment ES periods will provide data for a functional analysis of patients' drug use and urges to use. It is hypothesized that IATP conditions will yield significantly better coping skills acquisition than SMET-CB conditions, both at posttreatment and at extended follow-ups, and that change in coping skills will predict better outcomes for the IATP conditions
Detailed description
Marijuana is the most commonly used illicit drug in the US, but treatment for marijuana dependence is not fully effective. The most effective treatments to date have employed motivational enhancement (MET) plus cognitive-behavioral coping skills treatment (CB) and contingency management (CM) for abstinence. This proposal is a competitive renewal of our recently completed study to enhance coping and self-efficacy to improve marijuana outcomes in the long term. In the current proposal we are exploring the idea that more tailored teaching of coping skills may result in improved outcomes for marijuana-dependence than those seen thus far. The Individualized Assessment and Treatment Program (IATP) for marijuana dependent patients will employ experience sampling (ES) to determine the strengths and weaknesses of each patient in drug-use situations so that treatment can be tailored accordingly. Results from a pilot study indicated that IATP for alcohol dependent patients yielded better drinking outcomes at posttreatment than a packaged CB program (PCBT), that IATP patients reported greater use of coping skills than PCBT participants, and that posttreatment reports of coping skills were related to posttreatment drinking. Participants will be 275 men and women meeting criteria for marijuana dependence and randomly assigned to 9 sessions of treatment in one of 4 treatment conditions: Standardized MET plus CB (SMET-CB); SMET+ CM (SMET-CB-CM); IATP; or IATP + CM (IATP-CM). Patients in all treatments will engage in ES via cell-phone for two weeks prior to treatment, for a weekly period during treatment, for another week after treatment has ended, and for two weekly periods at months 8 and 14. In the IATP conditions, the information gathered from the pretreatment and during-treatment ES periods will provide data for a functional analysis of patients' drug use and urges to use. Therapists will use the information to address specific cognitions, affects, and behaviors that are adaptive and maladaptive, and will tailor a specific coping skills program with the patient. During-treatment experience sampling will allow adjustment of the treatment goals and procedures, making the treatment adaptive. In the SMET-CB conditions the experience sampling data will not be used in therapy, but will still provide in-vivo measures of drinking and coping skills. It is hypothesized that IATP conditions will yield significantly better coping skills acquisition than SMET-CB conditions, both at posttreatment and at extended follow-ups, and that change in coping skills will predict better outcomes for the IATP conditions. It is further predicted that the addition of CM to both IATP and SMET-CB will enhance short-term and long-term outcomes. The results will have implications for improved tailoring of treatment to patients' strength and deficits, and for the validity of the training of coping skills for relapse prevention. The data collected will shed light on the ways in which patients in treatment use coping skills in real-time contexts. Finally, the use of repeated ES periods will allow us to determine how treatment impacts thoughts, feelings and behaviors, and how these in turn affect outcome in the long and short term.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standardized MET plus CB (SMET-CB) | Active comparator | Behavioral: Cognitive-Behavioral TreatmentMotivational Enhancement plus Cognitive-Behavioral treatment |
| SMET+ CM (SMET-CB-CM) | Experimental | Behavioral: Contingency ManagementMotivational Enhancement plus CB treatment plus contingency management |
| Individualized Assessment & Treatment (IATP) | Experimental | Behavioral: Individualized Assessment & TreatmentIndividualized Assessment and Treatment Program; Cognitive-Behavioral Treatment based on in-depth field monitoring of patient behavior |
| IATP + CM (IATP-CM). | Experimental | Behavioral: Contingency Management, Behavioral: Individualized Assessment & TreatmentIndividualized Assessment and Treatment plus Contingency Management |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- at least 18 yrs old
- meet Diagnostic and Statistical Manual IV (DSM-IV) criteria for Cannabis Dependence
- be willing to accept random assignment to any of the 4 treatment conditions
Key exclusion criteria (4 listed)
- acute medical/psychiatric problems that require inpatient treatment (e.g., acute psychosis, severe depression, suicide/homicide risk)
- reading ability below the fifth grade level
- lack of reliable transportation
- excessive commuting distance.
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 |
|---|---|---|
| Contingency ManagementAlso: Positive ReinforcementReinforcement provided contingent upon demonstration of negative drug tests | Behavioural | IATP + CM (IATP-CM)., SMET+ CM (SMET-CB-CM) |
| Individualized Assessment & TreatmentAlso: IATPTailored Cognitive-Behavioral Treatment based on detailed records of patient behavior | Behavioural | IATP + CM (IATP-CM)., Individualized Assessment & Treatment (IATP) |
| Cognitive-Behavioral TreatmentAlso: CBTStandard psychoeducational approach to coping skills training | Behavioural | Standardized MET plus CB (SMET-CB) |
Primary outcome
Marijuana Use
Time frame: every 3 months
Marijuana use measured in terms of Days of use in every 90-day period
1 secondary outcome
Coping Skills
Time frame: every 3 months
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 21 Jun 2019.
- Derived from this study: PubMed 34014689Litt MD, Kadden RM, Tennen H, Dunn HK. Momentary coping and marijuana use in treated adults: Exploring mechanisms of treatment. J Consult Clin Psychol. 2021 Apr;89(4):264-276. doi: 10.1037/ccp0000633.
- Derived from this study: PubMed 31318225Litt MD, Kadden RM, Tennen H, Petry NM. Individualized assessment and treatment program (IATP) for cannabis use disorder: Randomized controlled trial with and without contingency management. Psychol Addict Behav. 2020 Feb;34(1):40-51. doi: 10.1037/adb0000491. Epub 2019 Jul 18.
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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.
Mark D Litt, PhD principal investigator
UConn Health
Elise Kabela-Cormier, PhD study director
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contingency Management, Individualized Assessment & Treatment and Cognitive-Behavioral Treatment in people with Marijuana Dependence, run by UConn Health 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 3 inclusion and 4 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 21 Jun 2019. 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.
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?
Marijuana Use (time frame: every 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 NCT02030665, which also lists 2 linked publications.
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 21 Jun 2019; AzTrials last refreshed its copy on 27 Oct 2026.