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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05328362
Other study ID # STUDY00032248
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 27, 2021
Est. completion date December 16, 2021

Study information

Verified date April 2022
Source Trustees of Dartmouth College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 55
Est. completion date December 16, 2021
Est. primary completion date December 16, 2021
Accepts healthy volunteers No
Gender All
Age group 19 Years to 25 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


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.

Locations

Country Name City State
United States Center for Technology and Behavioral Health Lebanon New Hampshire

Sponsors (2)

Lead Sponsor Collaborator
Trustees of Dartmouth College University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 2.8 hours after each decision point
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