PreventionSUPRA RCT R33NCT07672457
Substance Use Prevention for Recently Displaced Adults - SUPRA (R33) RCT
A study testing Acceptance and Commitment Therapy in people with Prevention and Substance Use, run by Boston Medical Center at 1 site in Ukraine.
Trial summary
This study is a randomized controlled trial among 144 internally displaced people to determine the feasibility, acceptability, and preliminary effectiveness of a single-session Acceptance of Commitment Therapy (ACT) group therapy on preventing or reducing substance use behaviors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prevention, Substance Use, Refugee Health
- What is being tested?
- Acceptance and Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUkraine
- Study dates
- Apr 2027to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age 18 or over
- Have been displaced at least once due to Anti-Terrorist Operation (ATO) or full-scale invasion since 2014
- Self-reported use of at least one substance other than alcohol and tobacco within the past 3 months
- Ability to provide informed consent and speak Ukrainian or Russian
Who cannot join
- Self-reported diagnosis of a substance use disorder
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kimberly Hook, PhD MA contact
Ukraine1 site
Alliance for Public Health
Kyiv
Pavlo Smyrnov, +380 44 490-5485, Smyrnov@aph.org.ua
About this study
This study is a randomized controlled trial among 144 internally displaced people to determine the feasibility, acceptability, and preliminary effectiveness of a single-session Acceptance of Commitment Therapy (ACT) group therapy on preventing or reducing substance use behaviors.
Read the detailed description
The war in Ukraine has provoked the world's current largest humanitarian displacement: since February 2022, over 13 million people, i.e., one-third of Ukrainians, have been forced to leave their homes, resulting in nearly 6 million internally displaced persons (IDPs). War and humanitarian emergencies may exacerbate substance use, but the incidence and prevalence of unhealthy substance use in humanitarian settings, including Ukraine, are currently largely unknown. This lack of data limits the ability to tailor targeted, effective preventive substance use interventions for these mobile populations. Addressing this knowledge gap is an immense priority for Ukraine, where rates of substance use were high even prior to the Russian invasion in February 2022, and in other settings hosting large populations of IDPs, including the United States.
To determine the feasibility, acceptability, and preliminary effectiveness of the intervention among IDPs, a RCT to evaluate implementation and substance use outcomes associated with the intervention at 1 and 6 months.
The investigators hypothesize that an ACT-based intervention delivered in a humanitarian context will help displaced persons in Ukraine build skills to manage stress and prevent or reduce substance use behaviors, ultimately mitigating the onset of substance use disorders.
- Conditions
- Prevention, Substance Use, Refugee Health
- Being tested
- Acceptance and Commitment Therapy, Attention Control
- Keywords
- Displacement, Ukraine, Substance Use
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyBehavioural
The ACT group intervention will involve a mixture of didactic instruction, discussion, and experiential activities. ACT will help internally displaced persons to manage stress and prevent or reduce substance use behaviors, ultimately mitigating the onset of substance use disorders.
Attention ControlBehavioural
Usual care will be minimally enhanced by providing participants with an educational information session that provides information on health promotion.
| Study group | Role | What they receive |
|---|---|---|
| ACT Therapy | Experimental | Participants randomized to this group will receive the ACT intervention Receives: Behavioral: Acceptance and Commitment Therapy |
| Attention Control | Active comparator | Participants in the control group will receive minimally enhanced usual care to receive treatment as usual enhanced by a health information group session. Receives: Behavioral: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the ACT Intervention
Feasibility will be assessed using the 14-item feasibility subscales of the Applied Mental Health Research Group Implementation Measure (AMHR-IM). Each item is rated on a 4-point scale where "0" means "not at all" and "3" means "a lot". The overall Feasibility score is calculated as the mean (average) across all 14 completed items, where higher scores (closer to 3) reflect a higher level of perceived feasibility of the intervention.
Measured: 1 month and 6 months
Acceptability of the ACT Intervention
Acceptability will be assessed using the 17-item acceptability subscales of the Applied Mental Health Research Group Implementation Measure (AMHR-IM). Each item is rated on a 4-point Likert scale where "0" means "not at all" and "3" means "a lot". The overall Acceptability score is calculated as the mean (average) across all 17 completed items, where higher scores (closer to 3) reflect a higher level of perceived acceptability of the intervention.
Measured: 1 month and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study startApr 2027 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreventionStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Karsten Lunze, MD DrPH MPH, Principal investigator, Boston University Chobanian & Avedisian School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07672457
- Sponsor's protocol ID
- H-46965
- Other IDs
- R33DA059856
- Acronym
- SUPRA RCT R33
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 29 Jun 2026
- 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 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substance Use Prevention for Recently Displaced Adults - SUPRA (R33) RCT
- ClinicalTrials.gov ID
- NCT07672457
- Acronym / sponsor ID
- SUPRA RCT R33 / H-46965
- Conditions
- Prevention, Substance Use, Refugee Health
- Keywords
- Displacement, Ukraine, Substance Use
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Apr 2027 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 29 Jun 2026 (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 is a randomized controlled trial among 144 internally displaced people to determine the feasibility, acceptability, and preliminary effectiveness of a single-session Acceptance of Commitment Therapy (ACT) group therapy on preventing or reducing substance use behaviors.
Detailed description
The war in Ukraine has provoked the world's current largest humanitarian displacement: since February 2022, over 13 million people, i.e., one-third of Ukrainians, have been forced to leave their homes, resulting in nearly 6 million internally displaced persons (IDPs). War and humanitarian emergencies may exacerbate substance use, but the incidence and prevalence of unhealthy substance use in humanitarian settings, including Ukraine, are currently largely unknown. This lack of data limits the ability to tailor targeted, effective preventive substance use interventions for these mobile populations. Addressing this knowledge gap is an immense priority for Ukraine, where rates of substance use were high even prior to the Russian invasion in February 2022, and in other settings hosting large populations of IDPs, including the United States.
To determine the feasibility, acceptability, and preliminary effectiveness of the intervention among IDPs, a RCT to evaluate implementation and substance use outcomes associated with the intervention at 1 and 6 months.
The investigators hypothesize that an ACT-based intervention delivered in a humanitarian context will help displaced persons in Ukraine build skills to manage stress and prevent or reduce substance use behaviors, ultimately mitigating the onset of substance use disorders.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT Therapy | Experimental | Behavioral: Acceptance and Commitment TherapyParticipants randomized to this group will receive the ACT intervention |
| Attention Control | Active comparator | Behavioral: Attention ControlParticipants in the control group will receive minimally enhanced usual care to receive treatment as usual enhanced by a health information group session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 or over
- Have been displaced at least once due to Anti-Terrorist Operation (ATO) or full-scale invasion since 2014
- Self-reported use of at least one substance other than alcohol and tobacco within the past 3 months
- Ability to provide informed consent and speak Ukrainian or Russian
Key exclusion criteria (2 listed)
- Self-reported diagnosis of a substance use disorder
- Inability to provide informed consent
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 and Commitment TherapyThe ACT group intervention will involve a mixture of didactic instruction, discussion, and experiential activities. ACT will help internally displaced persons to manage stress and prevent or reduce substance use behaviors, ultimately mitigating the onset of substance use disorders. | Behavioural | ACT Therapy |
| Attention ControlUsual care will be minimally enhanced by providing participants with an educational information session that provides information on health promotion. | Behavioural | Attention Control |
Primary outcome
Feasibility of the ACT Intervention
Time frame: 1 month and 6 months
Feasibility will be assessed using the 14-item feasibility subscales of the Applied Mental Health Research Group Implementation Measure (AMHR-IM). Each item is rated on a 4-point scale where "0" means "not at all" and "3" means "a lot". The overall Feasibility score is calculated as the mean (average) across all 14 completed items, where higher scores (closer to 3) reflect a higher level of perceived feasibility of the intervention.
Acceptability of the ACT Intervention
Time frame: 1 month and 6 months
Acceptability will be assessed using the 17-item acceptability subscales of the Applied Mental Health Research Group Implementation Measure (AMHR-IM). Each item is rated on a 4-point Likert scale where "0" means "not at all" and "3" means "a lot". The overall Acceptability score is calculated as the mean (average) across all 17 completed items, where higher scores (closer to 3) reflect a higher level of perceived acceptability of the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- 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.
Kimberly Hook, PhD MA contact
Karsten Lunze, MD DrPH MPH principal investigator
Boston University Chobanian & Avedisian School of Medicine
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 and Commitment Therapy in people with Prevention and Substance Use, run by Boston Medical Center at 1 site in Ukraine.
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 2 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: opening soon, as of the sponsor's last update on 29 Jun 2026. 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 Ukraine. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karsten Lunze, MD DrPH MPH (617-414-6933, lunze@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the ACT Intervention (time frame: 1 month and 6 months). 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 29 Jun 2026.