Computerized Exercise to Alter Stimulant Approach Responses
NCT ID: NCT03902405
Last Updated: 2021-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2018-06-11
2022-03-31
Brief Summary
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Detailed Description
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Hypothesis: 1) The intervention will be easy to integrate in the existing program. 2) Participation in the experimental (stimulant-avoidance) condition will reduce craving (as assessed by the stimulant craving questionnaire brief version), show reduction in an automatic association of activities with stimulant use and stimulant relapses (as assessed by behaviour association questionnaires) and have reduced relapses as assessed by urine drug screens in 12 weeks following initiation of the intervention.
Justification: Stimulant use disorders are among the most challenging disorders, specifically in individuals suffering from concurrent disorders or also identified as dual diagnosis. While medication is available to support the treatment of other substance use disorders (alcohol, opioids, tobacco), currently there is none to treat stimulant use disorders, such as cocaine use disorder and methamphetamine use disorder. Recently, a group in Europe developed the "retraining of automatic approach" intervention, which is based on simple mechanistic retraining for avoidance of substances. This method was successfully applied to change drinking behaviour in a sample of alcoholic inpatients. Participants respond to substance cues by initiating a distancing activity (pushing a joystick away). In contrast, healthy activities are "approached" or pulled in using the joystick. This differential activity trains participants to alter initial responses and "cognitive biases" to simply and automatically avoid substances.
Objectives: Test the hypothesis and evaluate whether or not the Computerized Exercise to Alter Stimulant Approach Responses (CEASAR) can improve stimulant use disorder outcomes in a population with concurrent disorders that are difficult to treat.
Research design: This study is a randomized, single blind, controlled trial involving in-patients with a stimulant use disorder. The participants will be split up equally into 2 groups: the active CEASAR intervention (experimental condition) and the placebo intervention (control). Patients are able to stay at the BCMHA for 6 months with the average being 4-5 months and the study will take place over 12 weeks during their stay. Both groups will use a joystick to push away ("avoid") or pull in ("approach") randomized stimulant and healthy cues presented on a computer screen. In the experimental condition, pushed pictures will exclusively be stimulant use-related pictures, while pulled pictures will be exclusively healthy. In the control condition, stimulant use-related pictures will be equally divided into push and pull conditions. Some of the cues will be visual (e.g. pictures of cocaine powder, pipes, needles etc.) and some of them will be textual (e.g. words like eight ball, rock, etc.).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Active CEASAR Intervention
Participants will be given the active CEASAR intervention where they will be trained to "avoid" cues associated with stimulant use and approach healthy cues based on the orientation of the images presented. Individuals will be asked to approach (pull in) portrait images and avoid (push away) landscape images. In the active condition, pushed pictures (landscape orientation) will exclusively be stimulant-use related pictures. Conversely, healthy images will be in the portrait orientation which will be pulled in.
Active CEASAR Intervention
Healthy and stimulant-use related pictures will be presented on a computer screen. Using a joystick, participants will be trained to pull in pictures that are presented in portrait orientation, and push those presented horizontally. In the active experimental condition, pushed pictures will exclusively be stimulant-related pictures.
Placebo CEASAR
In the control condition, stimulant use-related pictures will be randomized and equally divided into push (landscape) and pull (portrait) conditions.
Placebo CEASAR
In the control condition, stimulant cues and healthy cues will be randomized and stimulant use-related pictures will be equally divided into push and pull conditions.
Interventions
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Active CEASAR Intervention
Healthy and stimulant-use related pictures will be presented on a computer screen. Using a joystick, participants will be trained to pull in pictures that are presented in portrait orientation, and push those presented horizontally. In the active experimental condition, pushed pictures will exclusively be stimulant-related pictures.
Placebo CEASAR
In the control condition, stimulant cues and healthy cues will be randomized and stimulant use-related pictures will be equally divided into push and pull conditions.
Eligibility Criteria
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Inclusion Criteria
* 19 years of age or older
* Individuals with a current stimulant use disorder (cocaine, crack cocaine, amphetamine, methamphetamine, crystal meth), active before intake at BCMHA (as assessed by the MINI)
* Proficiency to read and write English and competent to provide consent
Exclusion Criteria
19 Years
70 Years
ALL
No
Sponsors
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University of British Columbia
OTHER
Responsible Party
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Christian Schutz
Associate Professor
Principal Investigators
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Christian Schutz, MD PhD MPH
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Locations
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Burnaby Centre for Mental Health and Addiction
Vancouver, British Columbia, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Wiers RW, Eberl C, Rinck M, Becker ES, Lindenmeyer J. Retraining automatic action tendencies changes alcoholic patients' approach bias for alcohol and improves treatment outcome. Psychol Sci. 2011 Apr;22(4):490-7. doi: 10.1177/0956797611400615. Epub 2011 Mar 9.
Wiers RW, Rinck M, Kordts R, Houben K, Strack F. Retraining automatic action-tendencies to approach alcohol in hazardous drinkers. Addiction. 2010 Feb;105(2):279-87. doi: 10.1111/j.1360-0443.2009.02775.x.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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H16-01099
Identifier Type: -
Identifier Source: org_study_id
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