NCT05328362

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 27, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 14, 2022

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

January 22, 2025

Completed
Last Updated

January 22, 2025

Status Verified

September 1, 2024

Enrollment Period

4 months

First QC Date

April 7, 2022

Results QC Date

October 27, 2023

Last Update Submit

December 2, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Minimum 2.8 hours after each decision point; Maximum 12.8 hours after each decision point

Study Arms (1)

CanCope Intervention

EXPERIMENTAL

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.

Behavioral: CanCope

Interventions

CanCopeBEHAVIORAL

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.

CanCope Intervention

Eligibility Criteria

Age19 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Used cannabis at least 10 out of the past 30 days

You may not qualify if:

  • Currently pregnant or breastfeeding
  • Currently in treatment for problems related to substance use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Technology and Behavioral Health

Lebanon, New Hampshire, 03766, United States

Location

Related Publications (1)

  • Stanger C, Anderson MAB, Xie H, Nnaka T, Budney AJ, Qian T, Yap JRT, Nahum-Shani I. Momentary mindfulness versus distraction coping messages to reduce cannabis craving among young adults: A microrandomized trial. Psychol Addict Behav. 2025 Mar;39(2):200-211. doi: 10.1037/adb0001029. Epub 2024 Oct 17.

Results Point of Contact

Title
Catherine Stanger
Organization
Dartmouth College

Study Officials

  • Catherine Stanger, PhD

    Dartmouth College

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Micro-Randomized Trial (MRT)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2022

First Posted

April 14, 2022

Study Start

August 27, 2021

Primary Completion

December 16, 2021

Study Completion

December 16, 2021

Last Updated

January 22, 2025

Results First Posted

January 22, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations