Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Computerized Exercise to Alter Stimulant Approach Responses (CEASAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03902405
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Christian Schutz, University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Amphetamine-Related Disorders Cocaine-Related Disorders Substance-Related Disorders Behavioral: Active CEASAR Intervention Behavioral: Placebo CEASAR Not Applicable

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.).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : June 11, 2018
Estimated Primary Completion Date : March 26, 2020
Estimated Study Completion Date : March 26, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Behavioral: 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 Comparator: Placebo CEASAR
In the control condition, stimulant use-related pictures will be randomized and equally divided into push (landscape) and pull (portrait) conditions.
Behavioral: 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.




Primary Outcome Measures :
  1. Changes in craving as assessed by the Stimulant Craving Questionnaire-Brief (SCQ-B) [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks ]
    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.

  2. Change in Behavioural association as assessed by the Behaviour Association Scale [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks ]

    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.


  3. Relapse to use as assessed by weekly self-reports and urine drug screens [ Time Frame: Between week 2 and week 12 ]
    Number of relapse days between week 2 and week 12 will be assessed.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03902405


Contacts
Layout table for location contacts
Contact: Anastasia Frank Cheng, MPH 604-827-4381 afrank@cheos.ubc.ca
Contact: Christian Schutz, MD PhD 778-873-4785 christian.schutz@ubc.ca

Locations
Layout table for location information
Canada, British Columbia
Burnaby Centre for Mental Health and Addiction Recruiting
Vancouver, British Columbia, Canada, V5G 3H4
Contact: Anastasia Frank Cheng, MPH    604-827-4381    afrank@cheos.ubc.ca   
Contact: Christian Schutz, MD PhD MPH    778-873-4785    christian.schutz@ubc.ca   
Sponsors and Collaborators
University of British Columbia
Investigators
Layout table for investigator information
Principal Investigator: Christian Schutz, MD PhD MPH University of British Columbia
  Study Documents (Full-Text)

Documents provided by Christian Schutz, University of British Columbia:
Publications:
Layout table for additonal information
Responsible Party: Christian Schutz, Associate Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT03902405    
Other Study ID Numbers: H16-01099
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Substance-Related Disorders
Cocaine-Related Disorders
Amphetamine-Related Disorders
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders