Marijuana UseBLUE-JNCT02837315
Improving Brief Marijuana Interventions With a Behavioral Economic Supplement
A study testing Brief Motivational Intervention (BMI), Substance-Free Activity Session (SFAS) and Relaxation Session in people with Marijuana Use, run by University of Memphis at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of a Substance-Free Activity Session (SFAS) as a supplement to a brief motivation intervention (BMI) in reducing marijuana use and drug-related consequences in college student Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Marijuana Use
- What is being tested?
- Brief Motivational Intervention (BMI), Substance-Free Activity Session (SFAS) and Relaxation Session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2014to 30 Nov 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- freshman or sophomore at the university of Memphis
- 5 or more past-month days of marijuana use
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the efficacy of a Substance-Free Activity Session (SFAS) as a supplement to a brief motivation intervention (BMI) in reducing marijuana use and drug-related consequences in college student
Read the detailed description
Approximately 20% of college students are regular marijuana users, and are at risk for cognitive and academic problems, addiction, and risk behaviors such as driving while impaired. Young adult marijuana users are thus a high-risk population and may require an intervention that motivates marijuana reductions by increasing engagement in constructive alternatives to marijuana use. Brief Motivational Interventions (BMIS) have demonstrated efficacy for alcohol use in college students, but lack consistent evidence of efficacy for marijuana use. This research team has developed a supplement to alcohol BMIs, the Substance-Free Activity Session (SFAS), which directly targets the behavioral economic mechanisms of both substance-free reinforcement and delayed reward discounting by encouraging the development of and commitment to academic and career goals, and by highlighting the impact of day-to-day patterns of alcohol use and academic engagement on these goals. A controlled pilot trial found that the SFAS improved BMI outcomes in a sample of heavy drinking college students, and the ongoing parent trial to this revision is replicating and extending those results. This study will evaluate the SFAS using a randomized 3-group (BMI + SFAS vs. BMI + Relaxation Attention Control, vs. Assessment Only) pilot trial with 120 undergraduates (50% female, 40% minority) who report using marijuana on > 5 days in the past-month. It is hypothesized that at the 1-month and the next-semester follow-ups (follow-ups are wedded to the academic calendar to allow for representative measurement of marijuana use and activity patterns) BMI+SFAS participants will report significantly lower levels of marijuana use and problems, and that these reductions will exceed those of BMI + Relaxation and Assessment-Only participants. Exploratory analyses will test the hypotheses that (a) the BMI + SFAS will be more effective for participants who report higher baseline marijuana reinforcing efficacy and delayed reward discounting; and (b) the advantage of BMI + SFAS on marijuana use will be mediated by increased participation in substance-free activities. Support for our hypotheses would extend behavioral economic theory and would provide initial validation for an approach that could be used to reduce marijuana misuse among the increasing population of college students who misuse marijuana. Furthermore, given the focus of the SFAS is to increase academic/campus engagement, this work has the potential for widespread dissemination.
- Conditions
- Marijuana Use
- Being tested
- Brief Motivational Intervention (BMI), Substance-Free Activity Session (SFAS), Relaxation Session
- Medical subject headings
- Marijuana Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Motivational Intervention (BMI)Behavioural
This session includes a discussion related to harm reduction and the student's autonomy to make decisions about the information provided in the session; a marijuana use decisional balance exercise; personalized marijuana-related feedback, and goal-setting. Elements included in the feedback are: (a) comparison of the student's perception of how much college students use marijuana and actual student norms, (b) a comparison of the student's marijuana use vs. norms, (c) drug-related problems experienced, (e) money spent on marijuana, and (f) alcohol norms and consequences if participants indicated they also drink alcohol. Participants discuss the personalized feedback with the clinician and review protective behavioral strategies if she or she indicates interest.
Substance-Free Activity Session (SFAS)Behavioural
The clinician initiates a discussion of the student's college and career goals. Students discuss the values that motivate them as well as how marijuana use may interfere with their ability to accomplish these goals. Students then receive information on graduation rates and income benefits for those who attend and excel in college. They receive personalized feedback on (a) the requirements for their major and intended career, (b) a list of extracurricular activities tailored to their goals, (c) a graph showing time they allocate to their activities, (d) information on stress and depressive symptoms (if applicable) and possible adaptive coping responses and (e) a list of substance-free recreational activities in which they would like to start or continuing engaging.
Relaxation SessionBehavioural
The session includes a clinician-led diaphragmatic breathing exercise, followed by a progressive muscle relaxation protocol (~30 minutes). At the end of the session, students are asked about their reaction to the relaxation techniques and are provided with relaxation training handouts.
| Study group | Role | What they receive |
|---|---|---|
| BMI + SFAS | Experimental | Participants first receive a 50-minute standard brief motivational intervention designed to reduce marijuana use. A week later, they will receive the SFAS (Substance-free Activity Session., a 50-minute counseling session designed to increase the salience of the student's academic and career goals, draw attention to the potentially negative relationship between substance use and goal accomplishment, and increase engagement in substance-free alternative activities. The SFAS was described to participants as the "College Adjustment Session" and the session was conducted using an MI plus personalized feedback approach. Receives: Behavioral: Brief Motivational Intervention (BMI); Behavioral: Substance-Free Activity Session (SFAS) |
| BMI + Relaxation Session | Active comparator | Participants first receive a 50-minute standard brief motivational intervention designed to reduce marijuana use. A week later, they will receive a relaxation training session. In the relaxation training session, the clinician leads the student through a diaphragmatic breathing exercise, followed by a progressive muscle relaxation protocol (~30 minutes). At the end of the session, students were asked about their reaction to the relaxation techniques and were provided with relaxation training handouts. Receives: Behavioral: Brief Motivational Intervention (BMI); Behavioral: Relaxation Session |
| Assessment | No intervention | Participants fill out a battery of measures and receive no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Marijuana use
Electronic timeline follow-back to measure marijuana use days
Measured: Baseline, 1-month, 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study start23 Oct 2014
- Primary completion30 Nov 2016
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Marijuana UseStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Memphis
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, James G Murphy, University of Memphis
- Investigators
- James G Murphy, Ph.D., Principal investigator, University of Memphis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02837315
- Sponsor's protocol ID
- 3R01AA020829-02S1
- Other IDs
- 4R01AA020829-05
- Acronym
- BLUE-J
- Status last verified
- May 2017
- First submitted
- 11 Jul 2016
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Researchers will maintain a de-identified database and after publishing the primary outcomes, they will make individual level data available to researchers who are conducting integrated analyses.
Publications
Murphy JG, Dennhardt AA, Utzelmann B, Borsari B, Ladd BO, Martens MP, White HR, Yurasek AM, Campbell KW, Witkiewitz K. A pilot trial of a brief intervention for cannabis use supplemented with a substance-free activity session or relaxation training. Psychol Addict Behav. 2024 May;38(3):255-268. doi: 10.1037/adb0000988. Epub 2024 Jan 25.
PubMed 38271079
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Brief Marijuana Interventions With a Behavioral Economic Supplement
- ClinicalTrials.gov ID
- NCT02837315
- Acronym / sponsor ID
- BLUE-J / 3R01AA020829-02S1
- Conditions
- Marijuana Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- University of MemphisUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 23 Oct 2014 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 19 Jul 2016 (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.
The purpose of this study is to evaluate the efficacy of a Substance-Free Activity Session (SFAS) as a supplement to a brief motivation intervention (BMI) in reducing marijuana use and drug-related consequences in college student
Detailed description
Approximately 20% of college students are regular marijuana users, and are at risk for cognitive and academic problems, addiction, and risk behaviors such as driving while impaired. Young adult marijuana users are thus a high-risk population and may require an intervention that motivates marijuana reductions by increasing engagement in constructive alternatives to marijuana use. Brief Motivational Interventions (BMIS) have demonstrated efficacy for alcohol use in college students, but lack consistent evidence of efficacy for marijuana use. This research team has developed a supplement to alcohol BMIs, the Substance-Free Activity Session (SFAS), which directly targets the behavioral economic mechanisms of both substance-free reinforcement and delayed reward discounting by encouraging the development of and commitment to academic and career goals, and by highlighting the impact of day-to-day patterns of alcohol use and academic engagement on these goals. A controlled pilot trial found that the SFAS improved BMI outcomes in a sample of heavy drinking college students, and the ongoing parent trial to this revision is replicating and extending those results. This study will evaluate the SFAS using a randomized 3-group (BMI + SFAS vs. BMI + Relaxation Attention Control, vs. Assessment Only) pilot trial with 120 undergraduates (50% female, 40% minority) who report using marijuana on > 5 days in the past-month. It is hypothesized that at the 1-month and the next-semester follow-ups (follow-ups are wedded to the academic calendar to allow for representative measurement of marijuana use and activity patterns) BMI+SFAS participants will report significantly lower levels of marijuana use and problems, and that these reductions will exceed those of BMI + Relaxation and Assessment-Only participants. Exploratory analyses will test the hypotheses that (a) the BMI + SFAS will be more effective for participants who report higher baseline marijuana reinforcing efficacy and delayed reward discounting; and (b) the advantage of BMI + SFAS on marijuana use will be mediated by increased participation in substance-free activities. Support for our hypotheses would extend behavioral economic theory and would provide initial validation for an approach that could be used to reduce marijuana misuse among the increasing population of college students who misuse marijuana. Furthermore, given the focus of the SFAS is to increase academic/campus engagement, this work has the potential for widespread dissemination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BMI + SFAS | Experimental | Behavioral: Brief Motivational Intervention (BMI), Behavioral: Substance-Free Activity Session (SFAS)Participants first receive a 50-minute standard brief motivational intervention designed to reduce marijuana use. A week later, they will receive the SFAS (Substance-free Activity Session., a 50-minute counseling session designed to increase the salience of the student's academic and career goals, draw attention to the potentially negative relationship between substance use and goal accomplishment, and increase engagement in substance-free alternative activities. The SFAS was described to participants as the "College Adjustment Session" and the session was conducted using an MI plus personalized feedback approach. |
| BMI + Relaxation Session | Active comparator | Behavioral: Brief Motivational Intervention (BMI), Behavioral: Relaxation SessionParticipants first receive a 50-minute standard brief motivational intervention designed to reduce marijuana use. A week later, they will receive a relaxation training session. In the relaxation training session, the clinician leads the student through a diaphragmatic breathing exercise, followed by a progressive muscle relaxation protocol (~30 minutes). At the end of the session, students were asked about their reaction to the relaxation techniques and were provided with relaxation training handouts. |
| Assessment | No intervention | –Participants fill out a battery of measures and receive no intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- freshman or sophomore at the university of Memphis
- 5 or more past-month days of marijuana use
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Brief Motivational Intervention (BMI)This session includes a discussion related to harm reduction and the student's autonomy to make decisions about the information provided in the session; a marijuana use decisional balance exercise; personalized marijuana-related feedback, and goal-setting. Elements included in the feedback are: (a) comparison of the student's perception of how much college students use marijuana and actual student norms, (b) a comparison of the student's marijuana use vs. norms, (c) drug-related problems experienced, (e) money spent on marijuana, and (f) alcohol norms and consequences if participants indicated they also drink alcohol. Participants discuss the personalized feedback with the clinician and review protective behavioral strategies if she or she indicates interest. | Behavioural | BMI + Relaxation Session, BMI + SFAS |
| Substance-Free Activity Session (SFAS)The clinician initiates a discussion of the student's college and career goals. Students discuss the values that motivate them as well as how marijuana use may interfere with their ability to accomplish these goals. Students then receive information on graduation rates and income benefits for those who attend and excel in college. They receive personalized feedback on (a) the requirements for their major and intended career, (b) a list of extracurricular activities tailored to their goals, (c) a graph showing time they allocate to their activities, (d) information on stress and depressive symptoms (if applicable) and possible adaptive coping responses and (e) a list of substance-free recreational activities in which they would like to start or continuing engaging. | Behavioural | BMI + SFAS |
| Relaxation SessionThe session includes a clinician-led diaphragmatic breathing exercise, followed by a progressive muscle relaxation protocol (~30 minutes). At the end of the session, students are asked about their reaction to the relaxation techniques and are provided with relaxation training handouts. | Behavioural | BMI + Relaxation Session |
Primary outcome
Change in Marijuana use
Time frame: Baseline, 1-month, 6-months
Electronic timeline follow-back to measure marijuana use 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 2 May 2017.
- Derived from this study: PubMed 38271079Murphy JG, Dennhardt AA, Utzelmann B, Borsari B, Ladd BO, Martens MP, White HR, Yurasek AM, Campbell KW, Witkiewitz K. A pilot trial of a brief intervention for cannabis use supplemented with a substance-free activity session or relaxation training. Psychol Addict Behav. 2024 May;38(3):255-268. doi: 10.1037/adb0000988. Epub 2024 Jan 25.
- Individual participant dataSharing planned: Yes. Researchers will maintain a de-identified database and after publishing the primary outcomes, they will make individual level data available to researchers who are conducting integrated analyses.
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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.
James G Murphy, Ph.D. principal investigator
University of Memphis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Motivational Intervention (BMI), Substance-Free Activity Session (SFAS) and Relaxation Session in people with Marijuana Use, run by University of Memphis 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 2 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 2 May 2017. 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?
Change in Marijuana use (time frame: Baseline, 1-month, 6-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 NCT02837315, which also lists 1 linked publication.
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 2 May 2017.