NCT03845842

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
311

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration 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

First Submitted

Initial submission to the registry

December 20, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

February 14, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 19, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

November 8, 2021

Status Verified

November 1, 2021

Enrollment Period

1.8 years

First QC Date

December 20, 2018

Last Update Submit

November 5, 2021

Conditions

Keywords

CannabisRisk reduction

Outcome Measures

Primary Outcomes (2)

  • Cannabis use reduction (amount)

    Self-reported cannabis use -amount of cannabis (weight)

    1 month

  • Cannabis use reduction (frequency)

    Self-reported cannabis use - frequency of use (days per week)

    1 month

Secondary Outcomes (3)

  • Self reported habit as measured by the automaticity subscale of the Self-Report Habit Index.

    1 month

  • Self reported action control as measured by the scale developed by Sniehotta et al (2011)

    1 month

  • Self reported craving as measured by items from the mood and physical symptoms scale (MPSS)

    1 month

Study Arms (2)

Control (volitional help sheet)

ACTIVE COMPARATOR

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.

Behavioral: Volitional help sheet

Intervention (volitional help sheet)

EXPERIMENTAL

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.

Behavioral: Volitional help sheet

Interventions

Participants are asked to choose from a list of strategies for avoiding cannabis use.

Control (volitional help sheet)Intervention (volitional help sheet)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Frequent cannabis user (at least fortnightly)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Manchester

Manchester, M13 9PL, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 16573874BACKGROUND
  • 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.

    PMID: 22935297BACKGROUND
  • 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.

    PMID: 15179542BACKGROUND

MeSH Terms

Conditions

Marijuana AbuseRisk Reduction Behavior

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersBehavior

Study Officials

  • Lynsey Gregg, PhD

    The University of Manchester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 20, 2018

First Posted

February 19, 2019

Study Start

February 14, 2019

Primary Completion

November 30, 2020

Study Completion

November 30, 2020

Last Updated

November 8, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations