Cannabis AbusePhase 2TMCU3NCT00350285
The Teen Marijuana Check-Up
A Phase 2 study testing Motivational enhancement therapy and Marijuana education in people with Cannabis Abuse and Cannabis Dependence, run by University of Washington.
Trial summary
This behavioral research is an efficacy trial evaluating an intervention called "The Teen Marijuana Check-Up" with non-treatment seeking adolescent marijuana users. Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis Abuse, Cannabis Dependence
- What is being tested?
- Motivational enhancement therapy and Marijuana education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- No sites listed yet
- Study dates
- Sep 2004to Jun 2008
- 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 14 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- they are not fluent in English,
- they have a thought disorder that precludes full participation,
- they refuse to accept randomization to condition.
- In addition to the inclusion and exclusion criteria, participants who appear to be in psychological or physical distress will be assessed further and referred to other services as appropriate. The need for other services will not necessarily preempt participation in the TMCU unless the individual is incapable or unwilling to complete the protocol. As was the case in our Stage 1b trial, all ineligible applicants will be offered a single feedback session, and the Strategies That Work booklet will be offered to those who indicate any interest in reducing or quitting marijuana use.
About this study
Official title: Reaching and Motivating Change in Teen Marijuana Smokers
This behavioral research is an efficacy trial evaluating an intervention called "The Teen Marijuana Check-Up" with non-treatment seeking adolescent marijuana users.
Read the detailed description
Three hundred adolescents who smoke marijuana (ages 14-19), recruited in four Seattle-area high schools, will be enrolled in the trial. Participants will be recruited either through in-class presentations focusing on marijuana or via referrals from school staff. They will first be assessed regarding use of marijuana, alcohol, and other drugs, as well as pertinent attitudes and goals. Participants will then be randomly assigned to one of three conditions.
- The experimental intervention is a two-session motivational enhancement treatment. A personalized feedback report, containing information from the participant's assessment as well as normative comparison data, is reviewed, with the Health Educator employing motivational interviewing strategies intended to enhance motivation for reduction or cessation of marijuana use. Specific goals for change and behavior change strategies are discussed with participants who wish support to change their marijuana use.
- The comparison condition involves two educational sessions focusing on the health and behavioral effects of marijuana.
- The third condition (delayed treatment control) involves a minimal baseline assessment followed three months later by a reassessment interview. Those assigned to this condition will then be given their choice of either active treatment.
Following completion of their two intervention sessions, participants in the two active treatments will be offered an additional four sessions of cognitive-behavioral skills training in which the focus is strategies in quitting marijuana. All participants will be reassessed at 3 and 12 months following their initial assessment interviews.
- Conditions
- Cannabis Abuse, Cannabis Dependence
- Being tested
- Motivational enhancement therapy, Marijuana education
- Keywords
- cannabis, marijuana
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational enhancement therapyBehavioural
Personal feedback with counselor using motivational interviewing strategies.
Marijuana educationBehavioural
Information about health and behavioral effects of marijuana use.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Motivational enhancement therapy Receives: Behavioral: Motivational enhancement therapy |
| 2 | Active comparator | Marijuana education Receives: Behavioral: Marijuana education |
| 3 | No intervention | Delayed treatment control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-report of marijuana use
Measured: 3 months and 12 months
Secondary outcomes (1)
Accepting abstinence-focused counseling
Measured: 3 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2006 (estimated)
- Study startSep 2004
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis AbuseStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Investigators
- Roger A Roffman, DSW, Principal investigator, University of Washington School of Social Work
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00350285
- Sponsor's protocol ID
- 01-8666-G-05
- Other IDs
- R01DA014296
- Acronym
- TMCU3
- Status last verified
- Oct 2008
- First submitted
- 5 Jul 2006
- Last updated
- 23 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2008. 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
- NCT00350285
- Acronym / sponsor ID
- TMCU3 / 01-8666-G-05
- Conditions
- Cannabis Abuse, Cannabis Dependence
- Keywords
- cannabis, marijuana
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2004
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 10 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.
This behavioral research is an efficacy trial evaluating an intervention called "The Teen Marijuana Check-Up" with non-treatment seeking adolescent marijuana users.
Detailed description
Three hundred adolescents who smoke marijuana (ages 14-19), recruited in four Seattle-area high schools, will be enrolled in the trial. Participants will be recruited either through in-class presentations focusing on marijuana or via referrals from school staff. They will first be assessed regarding use of marijuana, alcohol, and other drugs, as well as pertinent attitudes and goals. Participants will then be randomly assigned to one of three conditions.
- The experimental intervention is a two-session motivational enhancement treatment. A personalized feedback report, containing information from the participant's assessment as well as normative comparison data, is reviewed, with the Health Educator employing motivational interviewing strategies intended to enhance motivation for reduction or cessation of marijuana use. Specific goals for change and behavior change strategies are discussed with participants who wish support to change their marijuana use.
- The comparison condition involves two educational sessions focusing on the health and behavioral effects of marijuana.
- The third condition (delayed treatment control) involves a minimal baseline assessment followed three months later by a reassessment interview. Those assigned to this condition will then be given their choice of either active treatment.
Following completion of their two intervention sessions, participants in the two active treatments will be offered an additional four sessions of cognitive-behavioral skills training in which the focus is strategies in quitting marijuana. All participants will be reassessed at 3 and 12 months following their initial assessment interviews.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Motivational enhancement therapyMotivational enhancement therapy |
| 2 | Active comparator | Behavioral: Marijuana educationMarijuana education |
| 3 | No intervention | –Delayed treatment control condition |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- they are not fluent in English,
- they have a thought disorder that precludes full participation,
- they refuse to accept randomization to condition.
- In addition to the inclusion and exclusion criteria, participants who appear to be in psychological or physical distress will be assessed further and referred to other services as appropriate. The need for other services will not necessarily preempt participation in the TMCU unless the individual is incapable or unwilling to complete the protocol. As was the case in our Stage 1b trial, all ineligible applicants will be offered a single feedback session, and the Strategies That Work booklet will be offered to those who indicate any interest in reducing or quitting marijuana use.
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 |
|---|---|---|
| Motivational enhancement therapyPersonal feedback with counselor using motivational interviewing strategies. | Behavioural | 1 |
| Marijuana educationInformation about health and behavioral effects of marijuana use. | Behavioural | 2 |
Primary outcome
Self-report of marijuana use
Time frame: 3 months and 12 months
1 secondary outcome
Accepting abstinence-focused counseling
Time frame: 3 months and 12 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 23 Oct 2008.
Related trials for Cannabis Abuse
RecruitingPhase 3
Nabilone for Agitation Blinded Intervention Trial
Alzheimer Disease, Agitation
Active, not recruitingPhase 1
Psilocybin-assisted Treatment for Cannabis Use Disorder
Cannabis Use Disorder
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
RecruitingObservational study
Cannabis Abstinence and Neurocognitive Assessment in Adolescence
Cannabis Dependence, Harmful Use
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.
Roger A Roffman, DSW principal investigator
University of Washington School of Social Work
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Motivational enhancement therapy and Marijuana education in people with Cannabis Abuse and Cannabis Dependence, run by University of Washington.
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 0 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 23 Oct 2008. 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 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-report of marijuana use (time frame: 3 months and 12 months). 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 23 Oct 2008.