search
Back to results

CanCope: Digital Intervention for Coping With Cannabis Craving

Primary Purpose

Cannabis Use

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CanCope
Sponsored by
Trustees of Dartmouth College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis Use

Eligibility Criteria

19 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Center for Technology and Behavioral Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

CanCope mindfulness

CanCope distraction

CanCope attention control

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Proportion of decision points followed by decreased craving - Proximal outcome
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.

Secondary Outcome Measures

Full Information

First Posted
April 7, 2022
Last Updated
April 7, 2022
Sponsor
Trustees of Dartmouth College
Collaborators
University of Michigan
search

1. Study Identification

Unique Protocol Identification Number
NCT05328362
Brief Title
CanCope: Digital Intervention for Coping With Cannabis Craving
Official Title
CanCope: Digital Intervention for Coping With Cannabis Craving
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 27, 2021 (Actual)
Primary Completion Date
December 16, 2021 (Actual)
Study Completion Date
December 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trustees of Dartmouth College
Collaborators
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Micro-Randomized Trial (MRT)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CanCope mindfulness
Arm Type
Active Comparator
Arm Description
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.
Arm Title
CanCope distraction
Arm Type
Active Comparator
Arm Description
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.
Arm Title
CanCope attention control
Arm Type
Placebo Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
CanCope
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of decision points followed by decreased craving - Proximal outcome
Description
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.
Time Frame
2.8 hours after each decision point

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Molly A Anderson, PhD
Organizational Affiliation
Dartmouth College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Technology and Behavioral Health
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03766
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

CanCope: Digital Intervention for Coping With Cannabis Craving

We'll reach out to this number within 24 hrs