- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03845842
Using Implementation Intentions to Reduce Cannabis Use
Randomized Controlled Trial of a Volitional Help Sheet in Cannabis Users
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Manchester, United Kingdom, M13 9PL
- The University of Manchester
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
|---|---|
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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.
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Participants are asked to choose from a list of strategies for avoiding cannabis use.
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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.
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Participants are asked to choose from a list of strategies for avoiding cannabis use.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Cannabis use reduction (amount)
Time Frame: 1 month
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Self-reported cannabis use -amount of cannabis (weight)
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1 month
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Cannabis use reduction (frequency)
Time Frame: 1 month
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Self-reported cannabis use - frequency of use (days per week)
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1 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Self reported habit as measured by the automaticity subscale of the Self-Report Habit Index.
Time Frame: 1 month
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Self-reported habit (e.g., "Using cannabis is something I do automatically: strongly agree - strongly disagree).
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1 month
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Self reported action control as measured by the scale developed by Sniehotta et al (2011)
Time Frame: 1 month
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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")
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1 month
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Self reported craving as measured by items from the mood and physical symptoms scale (MPSS)
Time Frame: 1 month
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self reported craving
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1 month
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lynsey Gregg, PhD, The University of Manchester
Publications and helpful links
General Publications
- Sniehotta FF, Nagy G, Scholz U, Schwarzer R. The role of action control in implementing intentions during the first weeks of behaviour change. Br J Soc Psychol. 2006 Mar;45(Pt 1):87-106. doi: 10.1348/014466605X62460.
- Gardner B, Abraham C, Lally P, de Bruijn GJ. Towards parsimony in habit measurement: testing the convergent and predictive validity of an automaticity subscale of the Self-Report Habit Index. Int J Behav Nutr Phys Act. 2012 Aug 30;9:102. doi: 10.1186/1479-5868-9-102.
- West R, Hajek P. Evaluation of the mood and physical symptoms scale (MPSS) to assess cigarette withdrawal. Psychopharmacology (Berl). 2004 Dec;177(1-2):195-9. doi: 10.1007/s00213-004-1923-6. Epub 2004 Jun 4.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018 5701
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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