Methamphetamine AbuseNCT05334914
ACT for Methamphetamine Use Disorder in Women and Gender Non-Conforming Individuals
A study testing Acceptance Commitment Therapy in people with Methamphetamine Abuse and Methamphetamine-dependence, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
This study aims to assess the feasibility, acceptability and preliminary effectiveness of Acceptance Commitment Therapy, in conjunction with motivation enhancement, and the use of the ChillTime App, in reducing methamphetamine use in women with MUD with or without co-occurring psychiatric disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Methamphetamine Abuse, Methamphetamine-dependence
- What is being tested?
- Acceptance Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2024to 1 Apr 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet SCID DSM-5 criteria for Methamphetamine Use Disorder
- Over the age of 18
- Female, woman, or non-binary and comfortable participating in women's group
- Capacity to provide informed consent
- Adequate English language abilities
Who cannot join
- Experiencing acute or unmedicated psychosis that would reasonably prevent them from engaging in and/or benefiting from the intervention
- Experiencing acute and severe suicidal ideation such that institutionalization and supervised care is warranted
- Experiencing severe cognitive deficits that would reasonably prevent them from consenting, engaging in, and/or benefiting from the intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Online/In Person Program Assessing Acceptance Commitment Therapy Matrix Plus Contingency Management for Methamphetamine Use Disorder in Women and Gender Non-Conforming Individuals
This study aims to assess the feasibility, acceptability and preliminary effectiveness of Acceptance Commitment Therapy, in conjunction with motivation enhancement, and the use of the ChillTime App, in reducing methamphetamine use in women with MUD with or without co-occurring psychiatric disorders. This intervention is designed to be delivered remotely (e.g., participants can complete the entire study from home), with the option for in person attendance if it is not feasible or safe for participants to attend from home.
Read the detailed description
Women and gender non-conforming (GNC) individuals with methamphetamine use disorder (MUD) are a particularly vulnerable population in need of complex interventions that can address the range of severe clinical issues with which they often present. However, there are currently no existing psychosocial interventions that are considered preferred for MUD generally, much less in women and GNC individuals with complex psychological profiles and social positioning.
Complex interventions refer to a multifaceted approach to the treatment of psychiatric conditions and may consist of several therapeutic modalities (e.g., behavioural, pharmacological, technological, family engagement; May et al., 2007). These interventions are designed with the intent that they are easy to incorporate into everyday clinical practice (May et al., 2007) and will be effective in treating members of the general population, who present with complex conditions.
As such, the investigators aim to assess the feasibility, acceptability, and effectiveness of a) Acceptance Commitment Therapy delivered in a group format twice weekly, b) an intrinsic motivation building session and contingency management (i.e., progressive monetary incentivizing) targeting session attendance, and c) the ChillTime App to promote the use of emotional coping strategies between sessions.
The program will be 15 sessions/8 weeks long with outcome data collected at a 1-month follow up to assess longevity of effects on MUD harm reduction, abstinence, and mental health.
The investigators will recruit 60 participants through existing service providers in the Greater Toronto Area. As a broader aim of our study is to promote generalizability to the community and ensure the intervention will be accessible to all women and GNC individuals with MUDs, the following are implemented: a) group sessions will be delivered remotely, with an option for in person attendance if remote access is not feasible; b) broad inclusion criteria (e.g., not excluding on the basis of other mental health/substance use comorbidities); and c) qualitative interviews during which patient perspectives will be gathered and the intervention will be adapted accordingly, where warranted. Results will be used to inform a large-scale, randomized, controlled clinical trial.
Study Design: Each participant will undergo a screening/baseline assessment where they will complete clinical assessments to determine eligibility. Following the screening period and signing of the consent form, the study clinician will schedule a 1:1 motivation building session with participants. Participants will be given the 8-week ACT group schedule and research staff will assist them with downloading the ChillTime App. Over the course of the 8-week treatment, participants will learn coping and emotional regulation strategies, and will be able to access additional strategies through the use of the app. After the last group session, participants will once again complete clinical and quality of life assessments. The research staff administering the adverse events and outcome measures will not be the study clinician. The same questionnaires will be used at the 1 month follow-up, along with a qualitative interview asking about their satisfaction with and experience in the program as well as any changes in drug use reflective of harm reduction (e.g., stopped sharing pipes). Participants who missed a session will be offered the chance to make it up 1-1 with the study therapist; participants who dropped out of the group will also be contacted for an Early Termination Visit and will be asked to identify their reasons for dropping out.
- Conditions
- Methamphetamine Abuse, Methamphetamine-dependence
- Being tested
- Acceptance Commitment Therapy
- Keywords
- Methamphetamine use disorder, Acceptance commitment therapy, Contingency management, Motivational interviewing, App-based interventions, Telehealth, Women, Gender Non-Conforming, Non-binary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance Commitment TherapyBehavioural
Also called Contingency Management, Motivation Building, App-Based Therapy
ACT: Consists of 15 sessions, twice per week. Each session is approximately 2.5 hours including breaks. Clients cover 3 modules (OPEN, ACTIVE, AWARE). Any participant who requires access to a device for any part of the study will be provided with one for the duration of the study.
CM: Participants will be given progressive compensation for session attendance via gift cards or e-gift cards amounting to $520.
Motivation Building Session: The study clinician will meet with each of the participants to explain the process of the therapy, reinforce expectations, and address any concerns or hesitations, and build motivation and commitment to fully engage in the program.
ChillTime App Participants rate their emotional state and choose a coping strategy (either physical, emotional, cognitive or spiritual). The app's algorithm learns the individual's strategy preferences over time, allowing for more personalized suggestions. Participants are also able to access coping strategies ad hoc.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Other | Participants will complete the baseline session, a 1:1 motivation building session, and 8 weeks of ACT group therapy. They will then complete a final study visit and a follow-up study visit to occur 6 month after the end of therapy. Receives: Behavioral: Acceptance Commitment Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of intervention
Rates of eligible participants who agree to participate in the study intervention; Rates of retention in program (e.g., number of participants that completed all 15 sessions, number of participants that completed at least a full dose of 10 sessions, number of participants that dropped out before 10 sessions); Rate of use of ChillTime App
Measured: Immediately after intervention
Acceptability of intervention
Acceptance and understanding of the program using qualitative assessments at the end of study and the Client Satisfaction Questionnaire
Measured: 1 month follow-up
Secondary outcomes (12)
Changes in methamphetamine use via the timeline followback (TLFB)
The Timeline Followback (TLFB) is a method that can be used as a clinical and research tool to obtain a variety of quantitative estimates of methamphetamine use over the past 7-days
Measured: Baseline, immediately after intervention, 1 month follow-up
Changes in methamphetamine use via urinalysis
Liquid chromatography/mass spectrometry will be used to provide qualitative (yes/no) assessments of presence of methamphetamine in urine
Measured: Baseline, immediately after intervention, 1 month follow-up
Changes in other substance use via the Timeline Followback (TLFB)
The Timeline Followback (TLFB) is a method that can be used as a clinical and research tool to obtain a variety of quantitative estimates of other drug use over the past 7-days
Measured: Baseline, immediately after intervention, 1 month follow-up
Changes in anxiety via the Generalized Anxiety Disorder-7 (GAD-7)
The Generalized Anxiety Disorder Assessment (GAD-7) is a seven-item instrument that is used to measure or assess the severity of generalised anxiety disorder (GAD). Each item asks the individual to rate the severity of his or her symptoms over the past two weeks.
Measured: Baseline, immediately after intervention, 1 month follow-up
Changes in depression via the Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 is the nine item depression scale of the patient health questionnaire. The nine items of the PHQ-9 are based directly on the nine diagnostic criteria for major depressive disorder in the DSM-IV. The PHQ-9 can function as a screening tool, an aid in diagnosis, and as a symptom tracking tool that can help track a patient's overall depression severity as well as track the improvement of specific symptoms with treatment.
Measured: Baseline, immediately after intervention, 1 month follow-up
Changes in trauma symptoms via the Trauma Screening Questionnaire (TSQ)
The TSQ is a 10-item symptom screen that was designed for use with survivors of all types of traumatic stress. The TSQ is based on items from the PTSD Symptom Scale - Self Report (PSS-SR; Foa et al., 1993) and has five re-experiencing items and five arousal items.
Measured: Baseline, immediately after intervention, 1 month follow-up
Changes in acceptance commitment skills via the Acceptance and Action Questionnaire [AAQ-2
This 4-item measure uses 0-4 scale (0 = Not at All True; 4 = Very True) with lower sores correlating with higher psychological flexibility.
Measured: Baseline, immediately after intervention, 1 month follow-up
Changes in cravings/urges for methamphetamine via the Brief Substance Craving Scale BSCS
The BSCS is a 16 item, self-report instrument assesses craving for cocaine and other substances of abuse over a 24 hour period. Intensity and frequency of craving are recorded on a five-point Likert scale
Measured: Baseline, immediately after intervention, 1 month follow-up
Changes in quality of life, including well-being, relationships, social activities, personal fulfillment and recreation via the World Health Organization Quality of Life- BREF [WHOQOL-BREF]
Measures Quality of Life defined as an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns.
Measured: Baseline, immediately after intervention, 1 month follow-up
Drug use or harm reduction practices at the end of the study via semi-structured interviews
Semi-structured interview with member of research team
Measured: 1 month follow up
Barriers to engaging in the intervention using qualitative assessments at the end of study
Semi-structured interview with member of research team
Measured: 1 month follow up
Engagement in treatment
The Treatment Engagement Rating Scale was developed to assess patient engagement and behaviour change after an 8 week intervention; and will be adapted for this population. It is filled out by the study clinician for each participant.
Measured: Immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start1 Mar 2024 (estimated)
- Primary completion31 Mar 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine AbuseStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, open-label, feasibility trial
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bernard Le Foll, Centre for Addiction and Mental Health
- Investigators
- Bernard Le Foll, MD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334914
- Sponsor's protocol ID
- CAMH CCI ACT
- Status last verified
- Feb 2024
- First submitted
- 7 Apr 2022
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Online/In Person Program Assessing Acceptance Commitment Therapy Matrix Plus Contingency Management for Methamphetamine Use Disorder in Women and Gender Non-Conforming Individuals
- ClinicalTrials.gov ID
- NCT05334914
- Acronym / sponsor ID
- CAMH CCI ACT
- Conditions
- Methamphetamine Abuse, Methamphetamine-dependence
- Keywords
- Methamphetamine use disorder, Acceptance commitment therapy, Contingency management, Motivational interviewing, App-based interventions, Telehealth, Women, Gender Non-Conforming
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 19 Apr 2022 (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.
This study aims to assess the feasibility, acceptability and preliminary effectiveness of Acceptance Commitment Therapy, in conjunction with motivation enhancement, and the use of the ChillTime App, in reducing methamphetamine use in women with MUD with or without co-occurring psychiatric disorders. This intervention is designed to be delivered remotely (e.g., participants can complete the entire study from home), with the option for in person attendance if it is not feasible or safe for participants to attend from home.
Detailed description
Women and gender non-conforming (GNC) individuals with methamphetamine use disorder (MUD) are a particularly vulnerable population in need of complex interventions that can address the range of severe clinical issues with which they often present. However, there are currently no existing psychosocial interventions that are considered preferred for MUD generally, much less in women and GNC individuals with complex psychological profiles and social positioning.
Complex interventions refer to a multifaceted approach to the treatment of psychiatric conditions and may consist of several therapeutic modalities (e.g., behavioural, pharmacological, technological, family engagement; May et al., 2007). These interventions are designed with the intent that they are easy to incorporate into everyday clinical practice (May et al., 2007) and will be effective in treating members of the general population, who present with complex conditions.
As such, the investigators aim to assess the feasibility, acceptability, and effectiveness of a) Acceptance Commitment Therapy delivered in a group format twice weekly, b) an intrinsic motivation building session and contingency management (i.e., progressive monetary incentivizing) targeting session attendance, and c) the ChillTime App to promote the use of emotional coping strategies between sessions.
The program will be 15 sessions/8 weeks long with outcome data collected at a 1-month follow up to assess longevity of effects on MUD harm reduction, abstinence, and mental health.
The investigators will recruit 60 participants through existing service providers in the Greater Toronto Area. As a broader aim of our study is to promote generalizability to the community and ensure the intervention will be accessible to all women and GNC individuals with MUDs, the following are implemented: a) group sessions will be delivered remotely, with an option for in person attendance if remote access is not feasible; b) broad inclusion criteria (e.g., not excluding on the basis of other mental health/substance use comorbidities); and c) qualitative interviews during which patient perspectives will be gathered and the intervention will be adapted accordingly, where warranted. Results will be used to inform a large-scale, randomized, controlled clinical trial.
Study Design: Each participant will undergo a screening/baseline assessment where they will complete clinical assessments to determine eligibility. Following the screening period and signing of the consent form, the study clinician will schedule a 1:1 motivation building session with participants. Participants will be given the 8-week ACT group schedule and research staff will assist them with downloading the ChillTime App. Over the course of the 8-week treatment, participants will learn coping and emotional regulation strategies, and will be able to access additional strategies through the use of the app. After the last group session, participants will once again complete clinical and quality of life assessments. The research staff administering the adverse events and outcome measures will not be the study clinician. The same questionnaires will be used at the 1 month follow-up, along with a qualitative interview asking about their satisfaction with and experience in the program as well as any changes in drug use reflective of harm reduction (e.g., stopped sharing pipes). Participants who missed a session will be offered the chance to make it up 1-1 with the study therapist; participants who dropped out of the group will also be contacted for an Early Termination Visit and will be asked to identify their reasons for dropping out.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, open-label, feasibility trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Other | Behavioral: Acceptance Commitment TherapyParticipants will complete the baseline session, a 1:1 motivation building session, and 8 weeks of ACT group therapy. They will then complete a final study visit and a follow-up study visit to occur 6 month after the end of therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Meet SCID DSM-5 criteria for Methamphetamine Use Disorder
- Over the age of 18
- Female, woman, or non-binary and comfortable participating in women's group
- Capacity to provide informed consent
- Adequate English language abilities
Key exclusion criteria (3 listed)
- Experiencing acute or unmedicated psychosis that would reasonably prevent them from engaging in and/or benefiting from the intervention
- Experiencing acute and severe suicidal ideation such that institutionalization and supervised care is warranted
- Experiencing severe cognitive deficits that would reasonably prevent them from consenting, engaging in, and/or benefiting from the intervention
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 |
|---|---|---|
| Acceptance Commitment TherapyAlso: Contingency Management, Motivation Building, App-Based TherapyACT: Consists of 15 sessions, twice per week. Each session is approximately 2.5 hours including breaks. Clients cover 3 modules (OPEN, ACTIVE, AWARE). Any participant who requires access to a device for any part of the study will be provided with one for the duration of the study. CM: Participants will be given progressive compensation for session attendance via gift cards or e-gift cards amounting to $520. Motivation Building Session: The study clinician will meet with each of the participants to explain the process of the therapy, reinforce expectations, and address any concerns or hesitations, and build motivation and commitment to fully engage in the program. ChillTime App Participants rate their emotional state and choose a coping strategy (either physical, emotional, cognitive or spiritual). The app's algorithm learns the individual's strategy preferences over time, allowing for more personalized suggestions. Participants are also able to access coping strategies ad hoc. | Behavioural | Intervention Arm |
Primary outcome
Feasibility of intervention
Time frame: Immediately after intervention
Rates of eligible participants who agree to participate in the study intervention; Rates of retention in program (e.g., number of participants that completed all 15 sessions, number of participants that completed at least a full dose of 10 sessions, number of participants that dropped out before 10 sessions); Rate of use of ChillTime App
Acceptability of intervention
Time frame: 1 month follow-up
Acceptance and understanding of the program using qualitative assessments at the end of study and the Client Satisfaction Questionnaire
12 secondary outcomes
Changes in methamphetamine use via the timeline followback (TLFB)
Time frame: Baseline, immediately after intervention, 1 month follow-up
Changes in methamphetamine use via urinalysis
Time frame: Baseline, immediately after intervention, 1 month follow-up
Changes in other substance use via the Timeline Followback (TLFB)
Time frame: Baseline, immediately after intervention, 1 month follow-up
Changes in anxiety via the Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Baseline, immediately after intervention, 1 month follow-up
Changes in depression via the Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline, immediately after intervention, 1 month follow-up
Changes in trauma symptoms via the Trauma Screening Questionnaire (TSQ)
Time frame: Baseline, immediately after intervention, 1 month follow-up
Changes in acceptance commitment skills via the Acceptance and Action Questionnaire [AAQ-2
Time frame: Baseline, immediately after intervention, 1 month follow-up
Changes in cravings/urges for methamphetamine via the Brief Substance Craving Scale BSCS
Time frame: Baseline, immediately after intervention, 1 month follow-up
Changes in quality of life, including well-being, relationships, social activities, personal fulfillment and recreation via the World Health Organization Quality of Life- BREF [WHOQOL-BREF]
Time frame: Baseline, immediately after intervention, 1 month follow-up
Drug use or harm reduction practices at the end of the study via semi-structured interviews
Time frame: 1 month follow up
Barriers to engaging in the intervention using qualitative assessments at the end of study
Time frame: 1 month follow up
Engagement in treatment
Time frame: Immediately after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- 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.
Bernard Le Foll, MD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance Commitment Therapy in people with Methamphetamine Abuse and Methamphetamine-dependence, run by Centre for Addiction and Mental Health 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 5 inclusion and 3 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 8 Feb 2024. 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. 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 Pamela Sabioni, PhD (4165358501 ext. 31582, ACTforMUD@camh.ca; pamela.sabioni@camh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of intervention (time frame: Immediately after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2024.