Marijuana AbuseMOMENTNCT01762696
A Real-time, Contextual Intervention Using Mobile Technology to Reduce Marijuana Use in Youth
A study testing MET and MOMENT in people with Marijuana Abuse, run by Boston Children's Hospital at 2 sites in United States.
Trial summary
The purpose of this study is to further develop and test the Momentary Self-Monitoring and Feedback + Motivational Enhancement Therapy (MOMENT) intervention, a real-time, contextual intervention to reduce marijuana use among primary care patients. Read more about this study
- Who is it for?
- Ages 15 to 24 years
- Conditions the study is for
- Marijuana Abuse
- What is being tested?
- MET and MOMENT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2013to May 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 15 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female between the ages of 15-24 years
- Patient of the Boston Children's Hospital Adolescent/Young Adult Medicine Clinic or Martha Elliot Health Center Adolescent Clinic
- Ability to read and understand English
Who cannot join
- Medically or emotionally unstable, intoxicated or "high,", or otherwise unable to give consent at the time of their appointment
- Have previously participated in this study
- Does not meet the above inclusion criteria
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boston Children's Hospital Adolescent/Young Adult Medical Clinic
Boston, Massachusetts, 02115
Martha Eliot Health Center Adolescent Clinic
Jamaica Plain, Massachusetts, 02130
About this study
Official title: A Real-time, Contextual Intervention Using PDAs to Reduce Marijuana Use in Youth
The purpose of this study is to further develop and test the Momentary Self-Monitoring and Feedback + Motivational Enhancement Therapy (MOMENT) intervention, a real-time, contextual intervention to reduce marijuana use among primary care patients.
Read the detailed description
This study proposes a pilot randomized trial to further develop and test the Momentary Self-Monitoring and Feedback + Motivational Enhancement Therapy (MOMENT) intervention, a real-time, contextual intervention to reduce marijuana use over three months in 15-to-24-year-old primary care patients who use frequently. We will randomize youth to one of two arms (goal 30 per arm completing 3-month follow-up): 1) MOMENT (MET + momentary self-monitoring + context-dependent feedback), or 2) MET-only. The two study arms will permit evaluation of the contributions of the self-monitoring and feedback components of the intervention above-and-beyond the MET and directly test the influence of the intervention on the link between momentary context and marijuana-related outcomes.
The specific aims of the study are
Specific Aim 1: Continued Feasibility Evaluation. In our preliminary work, we demonstrated that 1) youth perceive MOMENT to be easy to understand, comfortable, motivating, and helpful in reducing their marijuana use, 2) we can recruit 4 participants/month (minimum rate for the proposed study), and 3) we can successfully implement a MOMENT intervention study in the proposed recruitment sites. Based on this work, we have identified additional areas of feasibility on which to focus in the proposed study. Specifically, we aim to achieve:
1a. A signal response rate of at least 70% during each of three periods of momentary data collection - baseline, intervention, and 3-month follow-up.
1b. A diary response rate of at least 70% during each momentary data collection period
- c. A retention rate of at least 80% of participants at the 3-month follow-up. Specific Aim 2. Early-Stage Efficacy Exploration. Our preliminary work showed that both momentary and individual-level outcomes improved from baseline to three months post-intervention. The primary momentary outcomes are desire to use marijuana when in a triggering context and likelihood of use following exposure to a triggering context. The primary individual-level outcomes are number of use events/week, 30-day percent of days abstinent, dose/use event, and measures of motivation (importance of, readiness for, and confidence about reducing use). Based on the preliminary findings, we will explore these early-stage efficacy questions:
- a. Will improvements in momentary outcomes be observed with MOMENT, but not MET-only? (1) The association between exposure to self-identified trigger contexts and momentary desire to use marijuana will be attenuated at three months, compared to pre-intervention. (2) The likelihood of marijuana use following exposure to a trigger context will be reduced at three months.
2b. Will improvements in individual-level outcomes be greater with MOMENT vs. MET-only?
- The reduction in marijuana use frequency (events/week and 30-day percent of days abstinent) and dose (per use event) will be greater at three months.
- The increase in motivation to reduce or discontinue use will be greater at three months.
- Conditions
- Marijuana Abuse
- Being tested
- MET, MOMENT
- Keywords
- marijuana, intervention, adolescent, young adult, primary care, mobile
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
METBehavioural
Also called Motivational Enhancement Therapy
Motivational Enhancement Therapy only
MOMENTBehavioural
The full MOMENT intervention: Motivational Enhancement Therapy + momentary and daily mobile self-monitoring + motivational feedback messages prompting participants to consider their individualized coping strategies to avoid using marijuana
| Study group | Role | What they receive |
|---|---|---|
| MET only | Active comparator | Motivational Enhancement Therapy only Receives: Behavioral: MET |
| MOMENT | Experimental | The full MOMENT intervention: Motivational Enhancement Therapy + momentary and daily mobile self-monitoring + motivational feedback messages prompting participants to consider their individualized coping strategies to avoid using marijuana Receives: Behavioral: MET; Behavioral: MOMENT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marijuana desire
Desire to use marijuana when in top-3 trigger context
Measured: 3 months
Marijuana use following trigger exposure
Marijuana use following exposure to top-3 trigger context
Measured: 3 months
Frequency of marijuana use
Marijuana use events/day
Measured: 3 months
Percent days abstinent
30-day percent days abstinent from marijuana use
Measured: 3 months
Motivation to reduce marijuana use
Daily score on 3 scales - readiness to reduce marijuana use, importance of reducing use, and confidence in ability to reduce use
Measured: 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 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2016
- Study completionMay 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 AbuseStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lydia Shrier, Boston Children's Hospital
- Investigators
- Lydia A Shrier, MD, MPH, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01762696
- Sponsor's protocol ID
- 1R34DA030535-01A1
- Acronym
- MOMENT
- Status last verified
- Dec 2016
- First submitted
- 4 Jan 2013
- Last updated
- 12 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shrier LA, Harris SK. Associations of Momentary Mindfulness With Affect and Cannabis Desire in a Trial of Cannabis Use Interventions With and Without Momentary Assessment. J Adolesc Health. 2023 Jan;72(1):126-129. doi: 10.1016/j.jadohealth.2022.09.002. Epub 2022 Oct 20.
PubMed 36272891
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-time, Contextual Intervention Using PDAs to Reduce Marijuana Use in Youth
- ClinicalTrials.gov ID
- NCT01762696
- Acronym / sponsor ID
- MOMENT / 1R34DA030535-01A1
- Conditions
- Marijuana Abuse
- Keywords
- marijuana, intervention, adolescent, young adult, primary care, mobile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 8 Jan 2013 (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 further develop and test the Momentary Self-Monitoring and Feedback + Motivational Enhancement Therapy (MOMENT) intervention, a real-time, contextual intervention to reduce marijuana use among primary care patients.
Detailed description
This study proposes a pilot randomized trial to further develop and test the Momentary Self-Monitoring and Feedback + Motivational Enhancement Therapy (MOMENT) intervention, a real-time, contextual intervention to reduce marijuana use over three months in 15-to-24-year-old primary care patients who use frequently. We will randomize youth to one of two arms (goal 30 per arm completing 3-month follow-up): 1) MOMENT (MET + momentary self-monitoring + context-dependent feedback), or 2) MET-only. The two study arms will permit evaluation of the contributions of the self-monitoring and feedback components of the intervention above-and-beyond the MET and directly test the influence of the intervention on the link between momentary context and marijuana-related outcomes.
The specific aims of the study are
Specific Aim 1: Continued Feasibility Evaluation. In our preliminary work, we demonstrated that 1) youth perceive MOMENT to be easy to understand, comfortable, motivating, and helpful in reducing their marijuana use, 2) we can recruit 4 participants/month (minimum rate for the proposed study), and 3) we can successfully implement a MOMENT intervention study in the proposed recruitment sites. Based on this work, we have identified additional areas of feasibility on which to focus in the proposed study. Specifically, we aim to achieve:
1a. A signal response rate of at least 70% during each of three periods of momentary data collection - baseline, intervention, and 3-month follow-up.
1b. A diary response rate of at least 70% during each momentary data collection period
- c. A retention rate of at least 80% of participants at the 3-month follow-up. Specific Aim 2. Early-Stage Efficacy Exploration. Our preliminary work showed that both momentary and individual-level outcomes improved from baseline to three months post-intervention. The primary momentary outcomes are desire to use marijuana when in a triggering context and likelihood of use following exposure to a triggering context. The primary individual-level outcomes are number of use events/week, 30-day percent of days abstinent, dose/use event, and measures of motivation (importance of, readiness for, and confidence about reducing use). Based on the preliminary findings, we will explore these early-stage efficacy questions:
- a. Will improvements in momentary outcomes be observed with MOMENT, but not MET-only? (1) The association between exposure to self-identified trigger contexts and momentary desire to use marijuana will be attenuated at three months, compared to pre-intervention. (2) The likelihood of marijuana use following exposure to a trigger context will be reduced at three months.
2b. Will improvements in individual-level outcomes be greater with MOMENT vs. MET-only?
- The reduction in marijuana use frequency (events/week and 30-day percent of days abstinent) and dose (per use event) will be greater at three months.
- The increase in motivation to reduce or discontinue use will be greater at three months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MET only | Active comparator | Behavioral: METMotivational Enhancement Therapy only |
| MOMENT | Experimental | Behavioral: MET, Behavioral: MOMENTThe full MOMENT intervention: Motivational Enhancement Therapy + momentary and daily mobile self-monitoring + motivational feedback messages prompting participants to consider their individualized coping strategies to avoid using marijuana |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Male or female between the ages of 15-24 years
- Patient of the Boston Children's Hospital Adolescent/Young Adult Medicine Clinic or Martha Elliot Health Center Adolescent Clinic
- Ability to read and understand English
Key exclusion criteria (3 listed)
- Medically or emotionally unstable, intoxicated or "high,", or otherwise unable to give consent at the time of their appointment
- Have previously participated in this study
- Does not meet the above inclusion criteria
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 |
|---|---|---|
| METAlso: Motivational Enhancement TherapyMotivational Enhancement Therapy only | Behavioural | MET only, MOMENT |
| MOMENTThe full MOMENT intervention: Motivational Enhancement Therapy + momentary and daily mobile self-monitoring + motivational feedback messages prompting participants to consider their individualized coping strategies to avoid using marijuana | Behavioural | MOMENT |
Primary outcome
Marijuana desire
Time frame: 3 months
Desire to use marijuana when in top-3 trigger context
Marijuana use following trigger exposure
Time frame: 3 months
Marijuana use following exposure to top-3 trigger context
Frequency of marijuana use
Time frame: 3 months
Marijuana use events/day
Percent days abstinent
Time frame: 3 months
30-day percent days abstinent from marijuana use
Motivation to reduce marijuana use
Time frame: 3 months
Daily score on 3 scales - readiness to reduce marijuana use, importance of reducing use, and confidence in ability to reduce use
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 12 Dec 2016.
- Derived from this study: PubMed 36272891Shrier LA, Harris SK. Associations of Momentary Mindfulness With Affect and Cannabis Desire in a Trial of Cannabis Use Interventions With and Without Momentary Assessment. J Adolesc Health. 2023 Jan;72(1):126-129. doi: 10.1016/j.jadohealth.2022.09.002. Epub 2022 Oct 20.
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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.
Lydia A Shrier, MD, MPH principal investigator
Boston Children's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MET and MOMENT in people with Marijuana Abuse, run by Boston Children's Hospital at 2 sites 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 3 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 12 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 desire (time frame: 3 months). The study lists 5 primary outcomes in all. 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 NCT01762696, 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 12 Dec 2016.