Trial Outcomes & Findings for CanCope: Digital Intervention for Coping With Cannabis Craving (NCT NCT05328362)
NCT ID: NCT05328362
Last Updated: 2025-01-22
Results Overview
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.
COMPLETED
NA
53 participants
Minimum 2.8 hours after each decision point; Maximum 12.8 hours after each decision point
2025-01-22
Participant Flow
Participants consented to the study in the app prior to completing any eligibility screening measures. Participants who consented but then failed to complete screening or any EMA assessments were not enrolled. EMA completion was required to randomize individual decision points (completed EMAs) to an intervention in this study design. N=53 were enrolled based on these criteria.
Participant milestones
| Measure |
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.
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.
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|---|---|
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Overall Study
STARTED
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53
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Overall Study
COMPLETED
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49
|
|
Overall Study
NOT COMPLETED
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4
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CanCope: Digital Intervention for Coping With Cannabis Craving
Baseline characteristics by cohort
| Measure |
CanCope Intervention
n=53 Participants
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.
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.
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|---|---|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=99 Participants
|
|
Age, Continuous
|
22.04 years
STANDARD_DEVIATION 1.97 • n=99 Participants
|
|
Sex/Gender, Customized
Gender · Man
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27 Participants
n=99 Participants
|
|
Sex/Gender, Customized
Gender · Woman
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20 Participants
n=99 Participants
|
|
Sex/Gender, Customized
Gender · Nonbinary
|
6 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
53 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Minimum 2.8 hours after each decision point; Maximum 12.8 hours after each decision pointPopulation: Only participants who completed baseline measures and at least one ecological momentary assessment (EMA) are included in the analyses. Two participants who completed baseline measures did not complete any EMAs which were required for micro-randomization and are therefore not included in the analyses.
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.
Outcome measures
| Measure |
CanCope Intervention
n=53 Participants
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 0.67 for receiving an active message (either a mindfulness or 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.
CanCope: Active 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) and clicked the intervention message, they received either an active coping strategy message or a control message. If participants reported craving levels of less than 4 they received a control message. It was pre-specified to combine the "mindfulness-based coping strategies" and "distraction-based coping strategies" interventions in the "Active Message" category for primary analyses. The study was powered a priori to detect differences in active vs. control messages.
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|---|---|
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Average Craving Level - Active vs. Control Messages
Active Message
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4.629 score on a scale
Standard Deviation 2.780
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Average Craving Level - Active vs. Control Messages
Control Message
|
4.736 score on a scale
Standard Deviation 2.822
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Adverse Events
CanCope Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place