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CanCope: Digital Intervention for Coping With Cannabis Craving

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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

Tracking Information
First Submitted Date  ICMJE April 7, 2022
First Posted Date  ICMJE April 14, 2022
Last Update Posted Date April 14, 2022
Actual Study Start Date  ICMJE August 27, 2021
Actual Primary Completion Date December 16, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CanCope: Digital Intervention for Coping With Cannabis Craving
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Micro-Randomized Trial (MRT)
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cannabis Use
Intervention  ICMJE 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 7, 2022)
55
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 16, 2021
Actual Primary Completion Date December 16, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 25 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05328362
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Current Responsible Party Trustees of Dartmouth College
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Trustees of Dartmouth College
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE University of Michigan
Investigators  ICMJE
Principal Investigator: Molly A Anderson, PhD Dartmouth College
PRS Account Trustees of Dartmouth College
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP