- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05328362
CanCope: Digital Intervention for Coping With Cannabis Craving
Study Overview
Detailed Description
The CanCope Study is designed to test the effectiveness of two distinct strategies (mindfulness and distraction) to cope with cannabis cravings in young adults (19 - 25 years) who are attempting to reduce their cannabis use. Cannabis use is determined using a single-item question about the number of days out of the past 30 days the individual used cannabis. Young adults who reported using cannabis >10 out of the past 30 days, who were not pregnant or breastfeeding, and who were not currently in treatment for problems related to substance use were eligible to enroll in this four-week study.
The CanCope intervention was delivered to participants through the MetricWire app, which was available for download on the participants' personal smartphones. Participants were asked to complete five ecological momentary assessments (EMA) per day, which asked questions related to cannabis use including one question about current level of craving on a scale of 0 - 10. If a participant reported a craving level >4, a message was sent via the app encouraging the participant to try a mindfulness or distraction coping strategy, or the participant received a thank-you for completing the EMA which served as an attention control.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New Hampshire
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Lebanon, New Hampshire, United States, 03766
- Center For Technology and Behavioral Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Used cannabis at least 10 out of the past 30 days
Exclusion Criteria:
- Currently pregnant or breastfeeding
- Currently in treatment for problems related to substance use
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: CanCope Intervention
The CanCope intervention was delivered through the MetricWire app which was available to each participant on their personal smartphone.
The intervention included a "push" component which was responsive to a participant's level of craving (based on self-report assessed via EMA) and sent messages to each participant via the MetricWire app according to a decision rule.
MetricWire randomized delivery of the push component with a probability of 0.33 for receiving a mindfulness coping strategy, 0.33 for receiving a distraction coping strategy, and 0.33 for receiving a thank-you message (attention control) at each decision point when participants were available for the intervention.
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Messages prompted participants to use mindfulness-based or distraction-based coping strategies, or a thank-you message which served as an attention control.
If participants reported elevated craving (4 or greater) prior to a decision point, they received either a coping strategy message or a control message.
If participants reported craving levels of less than 4 they received a control message.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Average Craving Level - Active vs. Control Messages
Time Frame: Minimum 2.8 hours after each decision point; Maximum 12.8 hours after each decision point
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Participants were asked to rate their level of cannabis craving on a scale of 0 - 10 five times per day where higher scores indicate more craving.
Participants were considered available for randomization when craving >=4 and they clicked the intervention message in the study app.
To determine the effect of messaging on craving, we will calculate the average craving level for each EMA eligible for intervention and randomized to receive an active coping strategy message or a control message.
It was pre-specified based on a priori power analyses for this small pilot study to combine the "mindfulness-based coping strategies" and "distraction-based coping strategies" interventions in the "Active Message" Row".
Craving levels will be averaged across randomized observations.
There were up to 140 decision points (5 EMAs per day x 28 days) per participant for the intervention period.
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Minimum 2.8 hours after each decision point; Maximum 12.8 hours after each decision point
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Catherine Stanger, PhD, Dartmouth College
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00032248
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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