Cannabis Use DisorderPhase 3NCT01109563
Teen Marijuana Check-Up
A Phase 3 study testing Marijuana Check-Ins in people with Cannabis Use Disorder, run by Denise Walker.
Trial summary
This study will test a behavioral intervention tailored for adolescents who smoke marijuana and have concerns about their use. The study's purpose is to determine whether this intervention (two-sessions of motivational enhancement intervention followed by 12 months of optional skills training) will be more effective… Read more about this study
- Who is it for?
- Ages 14 to 19 years
- Conditions the study is for
- Cannabis Use Disorder
- What is being tested?
- Marijuana Check-Ins
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Sep 2014
- Phase
- Phase 3
- 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 14 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age (14-19 years old),
- grade level (9th through 11th) and
- marijuana use.
Who cannot join
- Individuals will be excluded if:
- they are not fluent in English,
- they have a thought disorder that precludes full participation,
- they refuse to accept randomization to condition,
- they are high school seniors.
About this study
Official title: Reaching and Motivating Change in Teen Marijuana Smokers
This study will test a behavioral intervention tailored for adolescents who smoke marijuana and have concerns about their use. The study's purpose is to determine whether this intervention (two-sessions of motivational enhancement intervention followed by 12 months of optional skills training) will be more effective in reducing the use of this drug if augmented by three periodic motivational enhancement treatment check-in sessions as compared to three periodic computer-based check-in sessions.
HYPOTHESES: (1) Participants in the motivational enhancement treatment check-ins (MCI) condition will reduce their use of marijuana more than participants in the computer based (Comp) condition and report fewer negative consequences. These differences are expected to be greater at later follow-ups (i.e, 9, 12, and 15 months) after repeated check-ins exert a cumulative effect. (2)Engagement in CBT sessions will be greater for those in the MCI condition and will partially mediate the effect on marijuana related outcome indices. (3) The MCI intervention will lead to increased self-efficacy, and decreased normative perceptions of marijuana use by other teens that will also partially mediate the effect of the intervention.
Read the detailed description
The goal of this trial is to evaluate the efficacy of an enhanced Teen Marijuana Check-Up protocol to reach and intervene with non-treatment seeking adolescents who use marijuana heavily. Two hundred fifty adolescents who use marijuana heavily will receive a 2-session individual motivational enhancement therapy. All participants will also be offered the opportunity, over a 12-month period, to repeatedly re-initiate marijuana counseling. Participants will be randomly assigned to receive one of two types of periodic follow-up contacts: Motivational interviewing-based Marijuana Check-Ins (MCI) or Computer Based Control (Comp) sessions.
All participants will be reassessed at the 6, 9, 12, and 15-month anniversaries of enrollment. Following their initial motivational enhancement therapy, the 125 experimental condition participants will additionally have a motivational enhancement treatment "check-in" session with their counselor at the 4, 7, and 10-month anniversaries of enrollment intended to reinforce the maintenance of treatment gains and motivate continued success, increase motivation to change for participants who did not meet their marijuana use goals, and/or prompt utilization of cognitive-behavioral treatment (CBT) sessions as needed. The 125 comparison participants will complete a computer based questionnaire at the same time intervals to serve as an attentional control.
- Conditions
- Cannabis Use Disorder
- Being tested
- Marijuana Check-Ins
- Keywords
- cannabis use disorder, marijuana, motivational enhancement treatment, cognitive behavioral treatment, continuing care
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marijuana Check-InsBehavioural
The MCI, an MET intervention, will include the provision of personalized feedback with a motivational interviewing style. The focus of these sessions will be individualized to participants based on recent marijuana use and related experiences. Feedback given to participants during the MCI session will review progress toward goals as self-reported in percent days abstinent, normative data regarding marijuana use, review of reported consequences of marijuana use, review of abuse and dependence criteria reported, comparison of consequences and abuse and dependence symptoms reported over time, review of the positive outcomes from reductions in use, and review of immediate and long-term life goals and how their marijuana goal will affect these. HEs will offer particular encouragement to take advantage of CBT sessions to participants who feel they currently need treatment.
| Study group | Role | What they receive |
|---|---|---|
| Computer Check-In Control | Active comparator | The Computer Check-In gives the participant contact with the research therapist, an assessment of marijuana use and the current impact of use, and a reminder about optional support sessions. Receives: Behavioral: Marijuana Check-Ins |
| Marijuana Check-Ins | Experimental | The MCI, a MET intervention, will include the provision of personalized feedback with a motivational interviewing style. The focus of these sessions will be individualized to participants based on recent marijuana use and related experiences. Feedback given to participants during the MCI session will review progress toward goals as self-reported in percent days abstinent, normative data regarding marijuana use, review of reported consequences of marijuana use, review of abuse and dependence criteria reported, comparison of consequences and abuse and dependence symptoms reported over time, review of the positive outcomes from reductions in use, and review of immediate and long-term life goals and how their marijuana goal will affect these. HEs will offer particular encouragement to take advantage of CBT sessions to participants who feel they currently need treatment. Receives: Behavioral: Marijuana Check-Ins |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency (number of days) of marijuana use
Global Appraisal of Individual Needs - I (self-report measure)
Measured: 60 days
treatment utilization
Global Appraisal of Individual Needs - I
Measured: 90 days
marijuana abuse/dependence symptoms
Global Appraisal of Individual Needs - I
Measured: 60 days
engagement in cognitive behavioral skills training sessions
Frequency of attendance at optional in-school counseling sessions
Measured: 90 days
Secondary outcomes (2)
self-efficacy
Self-efficacy scale that assesses self-efficacy for avoiding marijuana use
Measured: 90 days
normative perceptions of peer marijuana use
Descriptive perceived norms concerning the frequency of marijuana use by other adolescents of the participant's age
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2010 (estimated)
- Study startMar 2011
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis Use DisorderStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Denise Walker
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Denise Walker, University of Washington
- Investigators
- Denise D Walker, PhD, Principal investigator, University of Washington School of Social Work
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01109563
- Sponsor's protocol ID
- 37852-G
- Other IDs
- 2R01DA014296-09A1
- Status last verified
- Oct 2016
- First submitted
- 21 Apr 2010
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reaching and Motivating Change in Teen Marijuana Smokers
- ClinicalTrials.gov ID
- NCT01109563
- Acronym / sponsor ID
- 37852-G
- Conditions
- Cannabis Use Disorder
- Keywords
- cannabis use disorder, marijuana, motivational enhancement treatment, cognitive behavioral treatment, continuing care
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Denise WalkerUniversity, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University, National Institute on Drug Abuse (NIDA)
- Study start
- Mar 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 23 Apr 2010 (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.
This study will test a behavioral intervention tailored for adolescents who smoke marijuana and have concerns about their use. The study's purpose is to determine whether this intervention (two-sessions of motivational enhancement intervention followed by 12 months of optional skills training) will be more effective in reducing the use of this drug if augmented by three periodic motivational enhancement treatment check-in sessions as compared to three periodic computer-based check-in sessions.
HYPOTHESES: (1) Participants in the motivational enhancement treatment check-ins (MCI) condition will reduce their use of marijuana more than participants in the computer based (Comp) condition and report fewer negative consequences. These differences are expected to be greater at later follow-ups (i.e, 9, 12, and 15 months) after repeated check-ins exert a cumulative effect. (2)Engagement in CBT sessions will be greater for those in the MCI condition and will partially mediate the effect on marijuana related outcome indices. (3) The MCI intervention will lead to increased self-efficacy, and decreased normative perceptions of marijuana use by other teens that will also partially mediate the effect of the intervention.
Detailed description
The goal of this trial is to evaluate the efficacy of an enhanced Teen Marijuana Check-Up protocol to reach and intervene with non-treatment seeking adolescents who use marijuana heavily. Two hundred fifty adolescents who use marijuana heavily will receive a 2-session individual motivational enhancement therapy. All participants will also be offered the opportunity, over a 12-month period, to repeatedly re-initiate marijuana counseling. Participants will be randomly assigned to receive one of two types of periodic follow-up contacts: Motivational interviewing-based Marijuana Check-Ins (MCI) or Computer Based Control (Comp) sessions.
All participants will be reassessed at the 6, 9, 12, and 15-month anniversaries of enrollment. Following their initial motivational enhancement therapy, the 125 experimental condition participants will additionally have a motivational enhancement treatment "check-in" session with their counselor at the 4, 7, and 10-month anniversaries of enrollment intended to reinforce the maintenance of treatment gains and motivate continued success, increase motivation to change for participants who did not meet their marijuana use goals, and/or prompt utilization of cognitive-behavioral treatment (CBT) sessions as needed. The 125 comparison participants will complete a computer based questionnaire at the same time intervals to serve as an attentional control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computer Check-In Control | Active comparator | Behavioral: Marijuana Check-InsThe Computer Check-In gives the participant contact with the research therapist, an assessment of marijuana use and the current impact of use, and a reminder about optional support sessions. |
| Marijuana Check-Ins | Experimental | Behavioral: Marijuana Check-InsThe MCI, a MET intervention, will include the provision of personalized feedback with a motivational interviewing style. The focus of these sessions will be individualized to participants based on recent marijuana use and related experiences. Feedback given to participants during the MCI session will review progress toward goals as self-reported in percent days abstinent, normative data regarding marijuana use, review of reported consequences of marijuana use, review of abuse and dependence criteria reported, comparison of consequences and abuse and dependence symptoms reported over time, review of the positive outcomes from reductions in use, and review of immediate and long-term life goals and how their marijuana goal will affect these. HEs will offer particular encouragement to take advantage of CBT sessions to participants who feel they currently need treatment. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- age (14-19 years old),
- grade level (9th through 11th) and
- marijuana use.
Key exclusion criteria (5 listed)
- they are not fluent in English,
- they have a thought disorder that precludes full participation,
- they refuse to accept randomization to condition,
- they are high school seniors.
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 |
|---|---|---|
| Marijuana Check-InsThe MCI, an MET intervention, will include the provision of personalized feedback with a motivational interviewing style. The focus of these sessions will be individualized to participants based on recent marijuana use and related experiences. Feedback given to participants during the MCI session will review progress toward goals as self-reported in percent days abstinent, normative data regarding marijuana use, review of reported consequences of marijuana use, review of abuse and dependence criteria reported, comparison of consequences and abuse and dependence symptoms reported over time, review of the positive outcomes from reductions in use, and review of immediate and long-term life goals and how their marijuana goal will affect these. HEs will offer particular encouragement to take advantage of CBT sessions to participants who feel they currently need treatment. | Behavioural | Computer Check-In Control, Marijuana Check-Ins |
Primary outcome
frequency (number of days) of marijuana use
Time frame: 60 days
Global Appraisal of Individual Needs - I (self-report measure)
treatment utilization
Time frame: 90 days
Global Appraisal of Individual Needs - I
marijuana abuse/dependence symptoms
Time frame: 60 days
Global Appraisal of Individual Needs - I
engagement in cognitive behavioral skills training sessions
Time frame: 90 days
Frequency of attendance at optional in-school counseling sessions
2 secondary outcomes
self-efficacy
Time frame: 90 days
normative perceptions of peer marijuana use
Time frame: 90 days
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 Oct 2016.
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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.
Denise D Walker, PhD principal investigator
University of Washington School of Social Work
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Marijuana Check-Ins in people with Cannabis Use Disorder, run by Denise Walker.
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 5 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 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
frequency (number of days) of marijuana use (time frame: 60 days). The study lists 4 primary outcomes in all. 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 Oct 2016; AzTrials last refreshed its copy on 31 Oct 2026.