Using Implementation Intentions to Reduce Cannabis Use

November 5, 2021 updated by: Lynsey Gregg, University of Manchester

Randomized Controlled Trial of a Volitional Help Sheet in Cannabis Users

The study will recruit frequent users of cannabis (defined at least fortnightly use) and randomize them either to: (1) form implementation intentions by linking situations in which they are tempted to use cannabis with strategies to avoid using cannabis in those situations by using a volitional help sheet, or (2) to consider the situations in which they are tempted to use cannabis alongside possible strategies to avoid using it as presented in the volitional help sheet but not to form implementation intentions. The effects on self-reported cannabis use will be assessed 1 month post-intervention. Predictors of cannabis reduction will also be examined.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Design: This study will use questionnaires to assess participants cannabis habits (frequency and amount of use) and then employ planning strategies to help them quit. Follow up questionnaires will be used to ascertain the success of planning on reduction in cannabis use.

Sample Size: We plan to recruit a minimum of 60 participants in each condition (120 total) but aim to collect data from as many participants as possible.

Recruitment: To participate in this study a person must be over the age of 18 and a frequent user of cannabis. The study will be advertised online on social media platforms.

Procedure: Potential participants will follow an online link to a briefing sheet that provides information about the study. The sheet will also inform participants that they do not have to complete the questionnaire and that they can withdraw from the study at any time without giving a reason. Once they have read the briefing sheet and generated their personal identity code, as instructed, they will complete the questionnaire online. A month after the participants have completed the initial questionnaire they will receive a link to a follow-up questionnaire via email. Email addresses will be stored separately to study data and will be destroyed once the follow up phase has completed and their involvement in the study ends.

Outcomes and Analysis: The main purpose of this study is to explore the role of planning in encouraging people to reduce cannabis use. Quantitative analysis will be conducted to assess the effects of planning on cannabis use reduction. The investigators expect to find that planning is effective in helping people reduce their use.

Study Type

Interventional

Enrollment (Actual)

311

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Manchester, United Kingdom, M13 9PL
        • The University of Manchester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Frequent cannabis user (at least fortnightly)

Exclusion Criteria:

  • Younger than 18 years of age
  • Infrequent / no cannabis use (less than fortnightly)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Control (volitional help sheet)
Participants read a brief statement designed to encourage them to reduce their cannabis use ("We want you to plan to reduce your cannabis use"). Participants are presented with a table with two columns and twenty rows. Twenty 'high risk' situations (temptations) are presented in the left hand column and 20 appropriate responses (processes of change) are presented in the right hand column (see Armitage, 2008). Participants are told that identifying situations in which they were tempted to use cannabis and identifying ways to overcome those temptations had been shown to help people change their behaviour and are asked to tick critical situations/appropriate responses that might be useful to them.
Participants are asked to choose from a list of strategies for avoiding cannabis use.
EXPERIMENTAL: Intervention (volitional help sheet)
Participants read a brief statement designed to encourage them to reduce their cannabis use ("We want you to plan to reduce your cannabis use"). Participants are presented with a table with two columns and twenty rows. Twenty 'high risk' situations (temptations) are presented in the left hand column and 20 appropriate responses (processes of change) are presented in the right hand column (see Armitage, 2008). Participants are told that identifying situations in which they were tempted to use cannabis and identifying ways to overcome those temptations had been shown to help people change their behaviour. Implementation intentions are formed by linking critical situations with appropriate responses by choosing an appropriate response from a drop down menu for each critical situation.
Participants are asked to choose from a list of strategies for avoiding cannabis use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cannabis use reduction (amount)
Time Frame: 1 month
Self-reported cannabis use -amount of cannabis (weight)
1 month
Cannabis use reduction (frequency)
Time Frame: 1 month
Self-reported cannabis use - frequency of use (days per week)
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self reported habit as measured by the automaticity subscale of the Self-Report Habit Index.
Time Frame: 1 month
Self-reported habit (e.g., "Using cannabis is something I do automatically: strongly agree - strongly disagree).
1 month
Self reported action control as measured by the scale developed by Sniehotta et al (2011)
Time Frame: 1 month
Self-reported action control (e.g., "During the last week I often had my intention to reduce my cannabis use on my mind: strongly disagree-strongly agree")
1 month
Self reported craving as measured by items from the mood and physical symptoms scale (MPSS)
Time Frame: 1 month
self reported craving
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Lynsey Gregg, PhD, The University of Manchester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 14, 2019

Primary Completion (ACTUAL)

November 30, 2020

Study Completion (ACTUAL)

November 30, 2020

Study Registration Dates

First Submitted

December 20, 2018

First Submitted That Met QC Criteria

February 15, 2019

First Posted (ACTUAL)

February 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 8, 2021

Last Update Submitted That Met QC Criteria

November 5, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2018 5701

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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