Cannabis Use
Conditions
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.
Interventions
BEHAVIORALCanCope
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.
Sponsors
University of Michigan
Trustees of Dartmouth College
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Micro-Randomized Trial (MRT)
Eligibility
Sex/Gender
ALL
Age
19 Years to 25 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Craving Level - Active vs. Control Messages | Minimum 2.8 hours after each decision point; Maximum 12.8 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 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 53 |
| Total | 53 |
Baseline characteristics
| Characteristic | CanCope Intervention |
|---|---|
| Age, Continuous | 22.04 years STANDARD_DEVIATION 1.97 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 42 Participants |
| Region of Enrollment United States | 53 participants |
| Sex/Gender, Customized Gender Man | 27 Participants |
| Sex/Gender, Customized Gender Nonbinary | 6 Participants |
| Sex/Gender, Customized Gender Woman | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 53 |
| other Total, other adverse events | 0 / 53 |
| serious Total, serious adverse events | 0 / 53 |
Outcome results
Primary
Average Craving Level - Active vs. Control Messages
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.
Time frame: Minimum 2.8 hours after each decision point; Maximum 12.8 hours after each decision point
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CanCope Intervention | Average Craving Level - Active vs. Control Messages | Control Message | 4.736 score on a scale | Standard Deviation 2.822 |
| CanCope Intervention | Average Craving Level - Active vs. Control Messages | Active Message | 4.629 score on a scale | Standard Deviation 2.78 |