Methamphetamine AbuseNCT05266716
Field Study of a Digital Therapeutic Platform to Facilitate Treatment for Methamphetamine-Primary Stimulant Use Disorder
A study testing Affect Methamphetamine Treatment Program in people with Methamphetamine Abuse, run by Affect Therapeutics, Inc. at 1 site in United States.
Trial summary
The overall purpose of the observational, investigational pilot study is to assess the clinical utility of the Affect digital health platform (the Affect® "app") as part of the Affect program of treatment for methamphetamine-primary stimulant use disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Methamphetamine Abuse
- What is being tested?
- Affect Methamphetamine Treatment Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2021to 7 Jan 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
To be eligible to participate in the study, prospective participants must:
- Be 18 years of age or older;
- Have methamphetamine use disorder (MUD) or documented high-risk methamphetamine use history, confirmed by DSM-5 criteria for stimulant use disorder, methamphetamine type;
- Have stated interest in reducing and/or stopping methamphetamine use;
- Have and be able to use a smartphone and agree to download and use the Affect app as part of treatment and study-related procedures;
- Have a health insurance plan (or Medicaid) to ensure that participants have access to medical care if needed;
- Be English speaking and have reading capacity sufficient to understand explanations of study procedures and the informed consent to participate;
- Be a California resident with a mailing address or P.O. Box
- Be able to freely give informed consent and be willing to electronically sign the digital informed consent to participate in the study;
- Be willing to comply with study procedures, including use of the Affect app consistent with the study protocol and therapeutic activities.
III.6 EXCLUSION CRITERIA
Individuals will be precluded from enrolling in the study if they endorse (or if there is documentation of) any of following conditions. Already enrolled participants will be withdrawn from study participation upon emergence of any excluded condition (except pregnancy):
- Serious medical diagnoses (e.g., seizure, stroke, heart disease);
- Serious mental illness (e.g., schizophrenia, bipolar, active suicidality);
- Moderate- to severe-level opioid use disorder or alcohol use disorder;
- Pregnancy;
- Have been in a prior study of pharmacological or behavioral treatment for MUD within 6 months of study consent;
- Be concurrently receiving other behavioral or pharmacological services for treatment of MUD;
- Have pending legal action or other situation that could inhibit consistent participation in the study or in study activities.
Trial locations and contacts
1 site in 1 country.
About this study
The overall purpose of the observational, investigational pilot study is to assess the clinical utility of the Affect digital health platform (the Affect® "app") as part of the Affect program of treatment for methamphetamine-primary stimulant use disorder. The study also will identify elements of the Affect app that enhance engagement of participants in the study toward the goal of improving patient outcomes, including reduction/cessation of stimulant use.
Read the detailed description
The research project is a single-group observational demonstration study to assess the clinical utility of a digital therapeutic technology (the Affect app) in terms of participant acceptance and the app's ability to enhance retention in the Affect program of services for the treatment of individuals with meth-primary stimulant use disorder (MUD). Measures of reduction and/or cessation of methamphetamine use will be assessed by saliva drug tests at least twice weekly during each participant's 8-week involvement in the program, at end of treatment, and via self-report at follow-up points at 1, 3, and 6 months after completion of the program. The app-based program will involve the same services for study participants as would occur regardless of the research, being a standard of care for MUD. The intervention phase of the study will be completed within approximately four months, with follow-ups of the final participants occurring approximately six months after the end of the intervention phase.
- Conditions
- Methamphetamine Abuse
- Being tested
- Affect Methamphetamine Treatment Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Affect Methamphetamine Treatment ProgramBehavioural
Components of the treatment services include: contingency management (CM; monetary incentives for drug tests negative for stimulants), the digital behavioral therapy curriculum (based on CBT) delivered via the Affect app on smartphones, weekly one-on-one telemedicine (TM) with clinical personnel and group therapy, and referral to psychiatrist for medication support, as needed. The program incrementally builds skills and beliefs to develop personally meaningful strategies to combat cravings, using such techniques as regular app-promoted deep breathing exercises, daily exercise, and help in making and sticking to a relapse prevention plan. Counseling sessions are arranged via text sent by the Team Care advocate and also presented to the participant via the app as a reminder. Individual and group therapy sessions occur over Zoom, which is integrated into the app.
Contingency Management (CM). CM utilizes monetary incentives and rewards to promote behavior change.
| Study group | Role | What they receive |
|---|---|---|
| Primary Arm | Experimental | The study will involve a total of approximately 48 individuals enrolled during a six-week period as participants in the field test of the Affect digital therapeutic platform Receives: Behavioral: Affect Methamphetamine Treatment Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant retention in treatment
Consistent with general approaches to measure retention (Hser et al., 2004, McLellan et al., 2006), the outcome will be based on completion as a binary measure at the end of the planned 8-week intervention for each participant. At the end-of-program telephone interview, participants will be deemed to be either treatment completers (i.e., retained) or dropouts (not retained if out of program before the end of week 4). Termination, expulsion, or unexplained non-response to or no contact with Affect personnel for more than seven consecutive days in any period of the 8-week study period equates to "drop-out" for the purpose of determining retention.
Measured: Up to 8 weeks through the duration of treatment
Participant participation in program
The nature/degree of participation in this study is a construct composed of the number of successfully "attended" therapeutic tasks/events/activities per the Affect app relative to not-attended events such as: scheduled/planned digital/virtual interactions for program activities (e.g., counseling, group meetings), completed biological assessments (remote drug saliva tests), and kept appointments with referred service providers (e.g., psychiatrists, physicians).
Measured: Up to 8 weeks through the duration of treatment
Participant engagement with the Affect app
Engagement with the Affect app components will be assessed via app-derived data on activity (i.e., duration, frequency, and consistency of involvement with app-directed tasks).
Measured: Up to 8 weeks through the duration of treatment
Participant satisfaction with the Affect app
The investigators will assess the results of surveys/questionnaires/focus groups to characterize participant satisfaction with the app and importance of its features in the overall treatment program.
Measured: Up to 8 weeks through the duration of treatment
Effectiveness in reducing meth use
The effectiveness measure is a composite of self-reported meth use (daily Yes/No) and meth-negative saliva test results (conducted remotely) over the course of each participant's 8-week duration in the program. A participant who provides at least 6 of 8 meth-negative saliva tests during the final 4 weeks of the 8-week program meets criteria for reduction/cessation of meth and thus demonstrates within-participant effectiveness of the program. Characteristics of the participants will be explored for possible associated factors that correlate with variations in outcomes across the sample.
Measured: Up to 8 weeks through the duration of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start18 Feb 2021
- Primary completion30 Jun 2021
- Study completion7 Jan 2022
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.
- 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
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affect Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Zito, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05266716
- Sponsor's protocol ID
- Methamphetamine Field Study
- Status last verified
- Feb 2022
- First submitted
- 7 Jan 2022
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No participant data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Field Study of a Digital Therapeutic Platform to Facilitate Treatment for Methamphetamine-Primary Stimulant Use Disorder
- ClinicalTrials.gov ID
- NCT05266716
- Acronym / sponsor ID
- Methamphetamine Field Study
- Conditions
- Methamphetamine Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Affect Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 7 Jan 2022 (actual)
- First posted
- 4 Mar 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.
The overall purpose of the observational, investigational pilot study is to assess the clinical utility of the Affect digital health platform (the Affect® "app") as part of the Affect program of treatment for methamphetamine-primary stimulant use disorder. The study also will identify elements of the Affect app that enhance engagement of participants in the study toward the goal of improving patient outcomes, including reduction/cessation of stimulant use.
Detailed description
The research project is a single-group observational demonstration study to assess the clinical utility of a digital therapeutic technology (the Affect app) in terms of participant acceptance and the app's ability to enhance retention in the Affect program of services for the treatment of individuals with meth-primary stimulant use disorder (MUD). Measures of reduction and/or cessation of methamphetamine use will be assessed by saliva drug tests at least twice weekly during each participant's 8-week involvement in the program, at end of treatment, and via self-report at follow-up points at 1, 3, and 6 months after completion of the program. The app-based program will involve the same services for study participants as would occur regardless of the research, being a standard of care for MUD. The intervention phase of the study will be completed within approximately four months, with follow-ups of the final participants occurring approximately six months after the end of the intervention phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary Arm | Experimental | Behavioral: Affect Methamphetamine Treatment ProgramThe study will involve a total of approximately 48 individuals enrolled during a six-week period as participants in the field test of the Affect digital therapeutic platform |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Affect Methamphetamine Treatment ProgramComponents of the treatment services include: contingency management (CM; monetary incentives for drug tests negative for stimulants), the digital behavioral therapy curriculum (based on CBT) delivered via the Affect app on smartphones, weekly one-on-one telemedicine (TM) with clinical personnel and group therapy, and referral to psychiatrist for medication support, as needed. The program incrementally builds skills and beliefs to develop personally meaningful strategies to combat cravings, using such techniques as regular app-promoted deep breathing exercises, daily exercise, and help in making and sticking to a relapse prevention plan. Counseling sessions are arranged via text sent by the Team Care advocate and also presented to the participant via the app as a reminder. Individual and group therapy sessions occur over Zoom, which is integrated into the app. Contingency Management (CM). CM utilizes monetary incentives and rewards to promote behavior change. | Behavioural | Primary Arm |
Primary outcome
Participant retention in treatment
Time frame: Up to 8 weeks through the duration of treatment
Consistent with general approaches to measure retention (Hser et al., 2004, McLellan et al., 2006), the outcome will be based on completion as a binary measure at the end of the planned 8-week intervention for each participant. At the end-of-program telephone interview, participants will be deemed to be either treatment completers (i.e., retained) or dropouts (not retained if out of program before the end of week 4). Termination, expulsion, or unexplained non-response to or no contact with Affect personnel for more than seven consecutive days in any period of the 8-week study period equates to "drop-out" for the purpose of determining retention.
Participant participation in program
Time frame: Up to 8 weeks through the duration of treatment
The nature/degree of participation in this study is a construct composed of the number of successfully "attended" therapeutic tasks/events/activities per the Affect app relative to not-attended events such as: scheduled/planned digital/virtual interactions for program activities (e.g., counseling, group meetings), completed biological assessments (remote drug saliva tests), and kept appointments with referred service providers (e.g., psychiatrists, physicians).
Participant engagement with the Affect app
Time frame: Up to 8 weeks through the duration of treatment
Engagement with the Affect app components will be assessed via app-derived data on activity (i.e., duration, frequency, and consistency of involvement with app-directed tasks).
Participant satisfaction with the Affect app
Time frame: Up to 8 weeks through the duration of treatment
The investigators will assess the results of surveys/questionnaires/focus groups to characterize participant satisfaction with the app and importance of its features in the overall treatment program.
Effectiveness in reducing meth use
Time frame: Up to 8 weeks through the duration of treatment
The effectiveness measure is a composite of self-reported meth use (daily Yes/No) and meth-negative saliva test results (conducted remotely) over the course of each participant's 8-week duration in the program. A participant who provides at least 6 of 8 meth-negative saliva tests during the final 4 weeks of the 8-week program meets criteria for reduction/cessation of meth and thus demonstrates within-participant effectiveness of the program. Characteristics of the participants will be explored for possible associated factors that correlate with variations in outcomes across the sample.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Individual participant dataSharing planned: No. No participant data will be shared.
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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.
Michael Zito, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Affect Methamphetamine Treatment Program in people with Methamphetamine Abuse, run by Affect Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 4 Mar 2022. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant retention in treatment (time frame: Up to 8 weeks through the duration of treatment). The study lists 5 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 4 Mar 2022.