Amphetamine-Related DisordersCEASARNCT03902405
Computerized Exercise to Alter Stimulant Approach Responses
A study testing Active CEASAR Intervention in people with Amphetamine-Related Disorders and Cocaine-Related Disorders, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Amphetamine-Related Disorders, Cocaine-Related Disorders, Substance-Related Disorders
- What is being tested?
- Active CEASAR Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 11 Jun 2018to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Individuals not stabilized enough to allow for regular participation in the intervention (determined by treating psychiatrist)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Burnaby Centre for Mental Health and Addiction
Vancouver, British Columbia, V5G 3H4
Anastasia Frank Cheng, MPH, 604-827-4381, afrank@cheos.ubc.ca
Christian Schutz, MD PhD MPH, 778-873-4785, christian.schutz@ubc.ca
About this study
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
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.
Read the 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.).
- Being tested
- Active CEASAR Intervention, Placebo CEASAR
- Medical subject headings
- Amphetamine-Related Disorders, Cocaine-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active CEASAR InterventionBehavioural
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 CEASARBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Active CEASAR Intervention | Active comparator | 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. Receives: Behavioral: Active CEASAR Intervention |
| Placebo CEASAR | Placebo comparator | In the control condition, stimulant use-related pictures will be randomized and equally divided into push (landscape) and pull (portrait) conditions. Receives: Behavioral: Placebo CEASAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
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.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
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.
Measured: Between week 2 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start11 Jun 2018
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Amphetamine-Related DisordersStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Schutz, University of British Columbia
- Investigators
- Christian Schutz, MD PhD MPH, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902405
- Sponsor's protocol ID
- H16-01099
- Acronym
- CEASAR
- Status last verified
- Jun 2021
- First submitted
- 27 Mar 2019
- Last updated
- 21 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21389338Wiers 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.
PubMed 20078486
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03902405
- Acronym / sponsor ID
- CEASAR / H16-01099
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 4 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active CEASAR Intervention | Active comparator | Behavioral: Active CEASAR InterventionParticipants 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. |
| Placebo CEASAR | Placebo comparator | Behavioral: Placebo CEASARIn the control condition, stimulant use-related pictures will be randomized and equally divided into push (landscape) and pull (portrait) conditions. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Individuals not stabilized enough to allow for regular participation in the intervention (determined by treating psychiatrist)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active CEASAR InterventionHealthy 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. | Behavioural | Active CEASAR Intervention |
| Placebo CEASARIn 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. | Behavioural | Placebo CEASAR |
Primary outcome
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
- Background: PubMed 21389338Wiers 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.
- Background: PubMed 20078486Wiers 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Schutz, MD PhD MPH principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active CEASAR Intervention in people with Amphetamine-Related Disorders and Cocaine-Related Disorders, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anastasia Frank Cheng, MPH (604-827-4381, afrank@cheos.ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in craving as assessed by the Stimulant Craving Questionnaire-Brief (SCQ-B) (time frame: Baseline, 4 weeks, 8 weeks, 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03902405, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2021.