NCT06822569

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for not_applicable

Timeline
21mo left

Started Dec 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress44%
Dec 2024Feb 2028

Study Start

First participant enrolled

December 27, 2024

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 12, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

April 2, 2025

Status Verified

March 1, 2025

Enrollment Period

3.1 years

First QC Date

January 6, 2025

Last Update Submit

March 27, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    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).

    Baseline, 1 year, 2 years

Study Arms (1)

Naturalistic, longitudinal

OTHER

Teenagers ages 13 to 16 years at the time of recruitment.

Other: Cue reactivity paradigm

Interventions

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).

Naturalistic, longitudinal

Eligibility Criteria

Age13 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brown University School of Public Health

Providence, Rhode Island, 02903, United States

RECRUITING

Related Publications (2)

  • 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.

    PMID: 23271193BACKGROUND
  • Tiffany 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.

    PMID: 8174499BACKGROUND

MeSH Terms

Conditions

Health BehaviorPsychological Well-BeingSubstance-Related Disorders

Condition Hierarchy (Ancestors)

BehaviorPersonal SatisfactionChemically-Induced DisordersMental Disorders

Central Study Contacts

Primary Researcher

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2025

First Posted

February 12, 2025

Study Start

December 27, 2024

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

April 2, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

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.

Locations