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Computerized Exercise to Alter Stimulant Approach Responses (CEASAR)

Primary Purpose

Amphetamine-Related Disorders, Cocaine-Related Disorders, Substance-Related Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Active CEASAR Intervention
Placebo CEASAR
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amphetamine-Related Disorders

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • In-patient of the Burnaby Centre of Mental Health & Addiction
  • 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:

  • Individuals not stabilized enough to allow for regular participation in the intervention (determined by treating psychiatrist)

Sites / Locations

  • Burnaby Centre for Mental Health and AddictionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active CEASAR Intervention

Placebo CEASAR

Arm Description

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.

In the control condition, stimulant use-related pictures will be randomized and equally divided into push (landscape) and pull (portrait) conditions.

Outcomes

Primary Outcome Measures

Changes in craving as assessed by the Stimulant Craving Questionnaire-Brief (SCQ-B)
Changes in craving will be assessed at baseline before the intervention, and at 4, 8, and 12 weeks after. It will be assessed by the Stimulant Craving Questionnaire-Brief (SCQ-B), which uses a 7-item scale (0 = Strongly Disagree, 6 = Strongly Agree) that can produce a composite score between 0 and 6. On this scale, lower scores indicate less craving which is considered a better outcome. Higher scores indicate more craving which is considered a worse outcome.
Change in Behavioural association as assessed by the Behaviour Association Scale
The Behaviour Association Scale measures association of substance use with different situations. Subscale 1, Word Associations: participants list the first word or phrase they associate with a given word. There are 13 word prompts, so the scale runs from 0 (no prompts associated with substance use) to 13 (all prompts associated with substance use). A low score is considered a better outcome because it means fewer situations are associated with substance use. Subscale 2, Behavioral Associations: operates the same way, except that there are 20 prompts listed so the scale runs from 0-20. These subscales are each measured on 2 dimensions, for a total of 4 dimensions to the scale. Dimension A: Each subscale is self-coded by the participant, where the participant determines if their response is substance-use related. Dimension B: Each subscale is researcher-coded, where 2 coders determine whether or not the response is unambiguously related to substance use.
Relapse to use as assessed by weekly self-reports and urine drug screens
Number of relapse days between week 2 and week 12 will be assessed.

Secondary Outcome Measures

Full Information

First Posted
March 27, 2019
Last Updated
June 18, 2021
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT03902405
Brief Title
Computerized Exercise to Alter Stimulant Approach Responses
Acronym
CEASAR
Official Title
CEASAR (Computerized Exercise to Alter Stimulant Approach Responses) - Piloting a Novel Intervention to Improve Outcomes in Individuals Suffering From Cocaine or Methamphetamine Use Disorder: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 11, 2018 (Actual)
Primary Completion Date
March 31, 2022 (Anticipated)
Study Completion Date
March 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the Computerized Exercise to Alter Stimulant Approach Responses (CEASAR), a novel stimulant use cessation intervention, for clients currently enrolled in a treatment centre for mental health and addiction. The investigators plan to conduct a randomized, single-blind controlled trial involving inpatients presenting with concurrent disorders to test the impact of this novel computerized intervention. This pilot study will be conducted at the Burnaby Centre for Mental Health and Addiction (BCMHA) in Burnaby, BC, Canada.
Detailed Description
Purpose: To examine a novel computerized exercise intervention as an add-on to currently available evidence-based stimulant use cessation treatments. This study will evaluate whether or not this intervention can improve stimulant use disorder outcomes in a population with concurrent disorders that are difficult to treat. 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.).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amphetamine-Related Disorders, Cocaine-Related Disorders, Substance-Related Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active CEASAR Intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo CEASAR
Arm Type
Placebo Comparator
Arm Description
In the control condition, stimulant use-related pictures will be randomized and equally divided into push (landscape) and pull (portrait) conditions.
Intervention Type
Behavioral
Intervention Name(s)
Active CEASAR Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Placebo CEASAR
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in craving as assessed by the Stimulant Craving Questionnaire-Brief (SCQ-B)
Description
Changes in craving will be assessed at baseline before the intervention, and at 4, 8, and 12 weeks after. It will be assessed by the Stimulant Craving Questionnaire-Brief (SCQ-B), which uses a 7-item scale (0 = Strongly Disagree, 6 = Strongly Agree) that can produce a composite score between 0 and 6. On this scale, lower scores indicate less craving which is considered a better outcome. Higher scores indicate more craving which is considered a worse outcome.
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks
Title
Change in Behavioural association as assessed by the Behaviour Association Scale
Description
The Behaviour Association Scale measures association of substance use with different situations. Subscale 1, Word Associations: participants list the first word or phrase they associate with a given word. There are 13 word prompts, so the scale runs from 0 (no prompts associated with substance use) to 13 (all prompts associated with substance use). A low score is considered a better outcome because it means fewer situations are associated with substance use. Subscale 2, Behavioral Associations: operates the same way, except that there are 20 prompts listed so the scale runs from 0-20. These subscales are each measured on 2 dimensions, for a total of 4 dimensions to the scale. Dimension A: Each subscale is self-coded by the participant, where the participant determines if their response is substance-use related. Dimension B: Each subscale is researcher-coded, where 2 coders determine whether or not the response is unambiguously related to substance use.
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks
Title
Relapse to use as assessed by weekly self-reports and urine drug screens
Description
Number of relapse days between week 2 and week 12 will be assessed.
Time Frame
Between week 2 and week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: In-patient of the Burnaby Centre of Mental Health & Addiction 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: Individuals not stabilized enough to allow for regular participation in the intervention (determined by treating psychiatrist)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anastasia Frank Cheng, MPH
Phone
604-827-4381
Email
afrank@cheos.ubc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Christian Schutz, MD PhD
Phone
778-873-4785
Email
christian.schutz@ubc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Schutz, MD PhD MPH
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Burnaby Centre for Mental Health and Addiction
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5G 3H4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anastasia Frank Cheng, MPH
Phone
604-827-4381
Email
afrank@cheos.ubc.ca
First Name & Middle Initial & Last Name & Degree
Christian Schutz, MD PhD MPH
Phone
778-873-4785
Email
christian.schutz@ubc.ca

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21389338
Citation
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.
Results Reference
background
PubMed Identifier
20078486
Citation
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.
Results Reference
background

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Computerized Exercise to Alter Stimulant Approach Responses

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