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CanCope: Digital Intervention for Coping With Cannabis Craving

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05328362
Recruitment Status : Completed
First Posted : April 14, 2022
Last Update Posted : April 14, 2022
Sponsor:
Collaborator:
University of Michigan
Information provided by (Responsible Party):
Trustees of Dartmouth College

Study Description
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Brief Summary:
The CanCope Study is a micro-randomized trial conducted to gather evidence about and compare the effectiveness of a momentary intervention to help young adults cope with cannabis cravings as they attempt to reduce their use.

Condition or disease Intervention/treatment Phase
Cannabis Use Behavioral: CanCope Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Micro-Randomized Trial (MRT)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CanCope: Digital Intervention for Coping With Cannabis Craving
Actual Study Start Date : August 27, 2021
Actual Primary Completion Date : December 16, 2021
Actual Study Completion Date : December 16, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: CanCope mindfulness
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.
 Behavioral: CanCope
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.
Active Comparator: CanCope distraction
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.
 Behavioral: CanCope
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.
Placebo Comparator: CanCope attention control
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.
 Behavioral: CanCope
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.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of decision points followed by decreased craving - Proximal outcome [ Time Frame: 2.8 hours after each decision point ]
    Participants were asked to rate their level of cannabis craving on a scale of 0 - 10 five times per day. Decision points occurred when participants submitted their cannabis craving rating. Participants were considered available for randomization when craving >=4. To determine the effect of messaging on craving, we will calculate the proportion of times a participant was available for intervention and craving at the subsequent EMA decreased when they were randomized to (1) mindfulness, (2) distraction, or (3) control out of the total number of times they were available and randomized to (1) mindfulness, (2) distraction, or (3) control. Proportions will be determined for each participant, then averaged across participants. There were up to 140 decision points (5 per day x 28 days) per participant for the intervention period.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05328362


Locations
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United States, New Hampshire
Center for Technology and Behavioral Health
Lebanon, New Hampshire, United States, 03766
Sponsors and Collaborators
Trustees of Dartmouth College
University of Michigan
Investigators
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Principal Investigator: Molly A Anderson, PhD Dartmouth College
More Information
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Responsible Party: Trustees of Dartmouth College
ClinicalTrials.gov Identifier: NCT05328362    
Other Study ID Numbers: STUDY00032248
First Posted: April 14, 2022    Key Record Dates
Last Update Posted: April 14, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders