Health BehaviorTHC&WNCT06822569
Teen Health Choices & Wellness
A study testing Cue reactivity paradigm in people with Health Behavior and Wellness, Psychological, run by Brown University at 1 site in United States.
Trial summary
The goal of this observational study is to learn more about changes in health, wellness, and substance-use behaviors as teenagers get older. Participants, ages 13 to 16, will be asked to use a smartphone application developed for this research study. Read more about this study
- Who is it for?
- Ages 13 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Wellness, Psychological, Substance Use
- What is being tested?
- Cue reactivity paradigm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Dec 2024to Feb 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 13 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- be age 13 to 16 years
- engage in a target health behavior on at least one recent occasion
- speak, read, and understand English or Spanish
- live in or near Rhode Island
Who cannot join
- lifetime history of moderate or severe substance use disorder or treatment, excluding nicotine use disorder
- current psychotic symptoms or active suicidality (i.e., intent in the past 30 days)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brown University School of Public Health
Providence, Rhode Island, 02903
Primary Researcher, 4018636623, teenhealth@brown.edu
Project Coordinator, 401-863-6670, teenhealth@brown.edu
About this study
The goal of this observational study is to learn more about changes in health, wellness, and substance-use behaviors as teenagers get older. Participants, ages 13 to 16, will be asked to use a smartphone application developed for this research study. Participants will also come to Brown University or meet via video conference to answer questions about specific behaviors, choices, and feelings that may change over time.
- Conditions
- Health Behavior, Wellness, Psychological, Substance Use
- Being tested
- Cue reactivity paradigm
- Medical subject headings
- Health Behavior, Psychological Well-Being, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cue reactivity paradigmOther
Participants will be exposed to cues in a fixed sequence while they answer questions about their emotions and thoughts. The cues will include everyday items (e.g., an ink pen) and substance-related items (e.g., a vape pen).
| Study group | Role | What they receive |
|---|---|---|
| Naturalistic, longitudinal | Other | Teenagers ages 13 to 16 years at the time of recruitment. Receives: Other: Cue reactivity paradigm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum subjective craving during cannabis cue exposure (rated on a 0 to 10 scale).
This study utilizes a structured cannabis cue exposure paradigm. During cue exposure, participants rate subjective craving on a scale from 0, "Not at all," to 10, "Extremely." The specific item to assess positive effects is the question, "How strong is your craving to use cannabis right now" sourced from the Morean' Drug Craving Questionnaire-Now. See reference section.
Measured: Baseline, 1 year, 2 years
Secondary outcomes (1)
Maximum subjective positive effects of cannabis use in daily life (rated on a 0 to 10 scale).
This study utilizes a smartphone application to collect self-reported subjective cannabis effects in the participant's daily life. Following a self-initiated report of cannabis use in daily life, participants rate subjective positive effects of cannabis at that moment (i.e., "right now") on a scale from 0, "Not at all," to 10, "Extremely." The specific item to assess positive effects is the question, "Do you like any of the effects you are feeling right now?" sourced from the Tiffany's Drug Effects Questionnaire. See reference section.
Measured: Baseline, 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start27 Dec 2024
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (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 Health BehaviorStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822569
- Sponsor's protocol ID
- 2023003584
- Other IDs
- R01DA055600
- Acronym
- THC&W
- Status last verified
- Sep 2026
- First submitted
- 6 Jan 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data that cannot individually identify participants may be shared with researchers internal and external to Brown University upon reasonable request by qualified research collaborators. Data shared with qualified researchers will not contain any protected health information or other personally identifiable information that could be used to identify individual participants.
Publications
Morean ME, de Wit H, King AC, Sofuoglu M, Rueger SY, O'Malley SS. The drug effects questionnaire: psychometric support across three drug types. Psychopharmacology (Berl). 2013 May;227(1):177-92. doi: 10.1007/s00213-012-2954-z. Epub 2012 Dec 28.
PubMed 23271193Tiffany ST, Singleton E, Haertzen CA, Henningfield JE. The development of a cocaine craving questionnaire. Drug Alcohol Depend. 1993 Dec;34(1):19-28. doi: 10.1016/0376-8716(93)90042-o.
PubMed 8174499
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teen Health Choices & Wellness
- ClinicalTrials.gov ID
- NCT06822569
- Acronym / sponsor ID
- THC&W / 2023003584
- Conditions
- Health Behavior, Wellness, Psychological, Substance Use
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 27 Dec 2024 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 12 Feb 2025 (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 goal of this observational study is to learn more about changes in health, wellness, and substance-use behaviors as teenagers get older. Participants, ages 13 to 16, will be asked to use a smartphone application developed for this research study. Participants will also come to Brown University or meet via video conference to answer questions about specific behaviors, choices, and feelings that may change over time.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Naturalistic, longitudinal | Other | Other: Cue reactivity paradigmTeenagers ages 13 to 16 years at the time of recruitment. |
Who may qualify
- Ages
- 13 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- be age 13 to 16 years
- engage in a target health behavior on at least one recent occasion
- speak, read, and understand English or Spanish
- live in or near Rhode Island
Key exclusion criteria (2 listed)
- lifetime history of moderate or severe substance use disorder or treatment, excluding nicotine use disorder
- current psychotic symptoms or active suicidality (i.e., intent in the past 30 days)
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 |
|---|---|---|
| Cue reactivity paradigmParticipants will be exposed to cues in a fixed sequence while they answer questions about their emotions and thoughts. The cues will include everyday items (e.g., an ink pen) and substance-related items (e.g., a vape pen). | Other | Naturalistic, longitudinal |
Primary outcome
Maximum subjective craving during cannabis cue exposure (rated on a 0 to 10 scale).
Time frame: Baseline, 1 year, 2 years
This study utilizes a structured cannabis cue exposure paradigm. During cue exposure, participants rate subjective craving on a scale from 0, "Not at all," to 10, "Extremely." The specific item to assess positive effects is the question, "How strong is your craving to use cannabis right now" sourced from the Morean' Drug Craving Questionnaire-Now. See reference section.
1 secondary outcome
Maximum subjective positive effects of cannabis use in daily life (rated on a 0 to 10 scale).
Time frame: Baseline, 1 year, 2 years
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 Sep 2026.
- Background: PubMed 23271193Morean ME, de Wit H, King AC, Sofuoglu M, Rueger SY, O'Malley SS. The drug effects questionnaire: psychometric support across three drug types. Psychopharmacology (Berl). 2013 May;227(1):177-92. doi: 10.1007/s00213-012-2954-z. Epub 2012 Dec 28.
- Background: PubMed 8174499Tiffany ST, Singleton E, Haertzen CA, Henningfield JE. The development of a cocaine craving questionnaire. Drug Alcohol Depend. 1993 Dec;34(1):19-28. doi: 10.1016/0376-8716(93)90042-o.
- Individual participant dataSharing planned: Yes. De-identified data that cannot individually identify participants may be shared with researchers internal and external to Brown University upon reasonable request by qualified research collaborators. Data shared with qualified researchers will not contain any protected health information or other personally identifiable information that could be used to identify individual participants.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cue reactivity paradigm in people with Health Behavior and Wellness, Psychological, run by Brown University 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?
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: looking for participants now, as of the sponsor's last update on 29 Sep 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 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?
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 Primary Researcher (401-863-6623, teenhealth@brown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum subjective craving during cannabis cue exposure (rated on a 0 to 10 scale). (time frame: Baseline, 1 year, 2 years). 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 NCT06822569, 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 29 Sep 2026.