CanCope: Digital Intervention for Coping With Cannabis Craving

• ClinicalTrials.gov Identifier: NCT05328362
• Recruitment Status: Completed
• First Posted: April 14, 2022
• Last Update Posted: April 14, 2022
• Sponsor: Trustees of Dartmouth College
• Collaborator: University of Michigan
• Information provided by (Responsible Party): Trustees of Dartmouth College

Tracking Information

• First Submitted Date: April 7, 2022
• First Posted Date: April 14, 2022
• Last Update Posted Date: April 14, 2022
• Actual Study Start Date: August 27, 2021
• Actual Primary Completion Date: December 16, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 7, 2022)

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: CanCope: Digital Intervention for Coping With Cannabis Craving
• Official Title: CanCope: Digital Intervention for Coping With Cannabis Craving
• 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.

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: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Micro-Randomized Trial (MRT)

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Cannabis Use

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.

Study Arms

• 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.
  Intervention: Behavioral: CanCope
• 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.
  Intervention: Behavioral: CanCope
• 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.
  Intervention: Behavioral: CanCope

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 7, 2022): 55
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 16, 2021
• Actual Primary Completion Date: December 16, 2021 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 19 Years to 25 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05328362
• Other Study ID Numbers: STUDY00032248
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Trustees of Dartmouth College
• Original Responsible Party: Same as current
• Current Study Sponsor: Trustees of Dartmouth College
• Original Study Sponsor: Same as current
• Collaborators: University of Michigan

Investigators

• Principal Investigator: Molly A Anderson, PhD; Dartmouth College

• PRS Account: Trustees of Dartmouth College
• Verification Date: April 2022