Recruiting

Observational Study

Sponsor:

Brown University

Code:

NCT07731295

Conditions

Pain, Postoperative

Substance Use

Eligibility Criteria

Sex: All

Age: 15 - 20

Healthy Volunteers: Accepted

Interventions

iPAWS

Educational Materials

Study Details

Brief summary:

This is a clinical trial that will evaluate the feasibility and acceptability of a virtual brief program for adolescents and young adults undergoing wisdom tooth extraction and their parents. The program aims to teach youth safe and effective ways to manage post-surgical pain as well as decrease risky health behaviors.

Conditions

Pain, Postoperative

Substance Use

Study ID

NCT07731295

Start date

Jun 29, 2026

Status verified date

May, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 20

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Ages 15 to 20 years
  • Undergoing wisdom tooth extraction for the first time
  • Able to read simple English
  • \*Endorse cannabis use at least two days per week on average in the past 28 days

\*The investigator aims to recruit at least 50 participants who are using cannabis at least two days per week in the past 28 days on average and will recruit up to 100 additional participants who use other substances, use cannabis at a lesser intensity, or do not use any substances.
  • (Parent/Guardian only) - Have a child who is undergoing wisdom tooth surgery and is participating in the study

Exclusion Criteria:

\- N/A

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: iPAWS Intervention

Participants in the experimental condition will receive standard practice educational materials and the iPAWS self-guided, digital intervention.

active comparator: Educational Materials

Participants in the control condition will receive standard practice educational materials (i.e., in the form of a brochure).

Interventions

iPAWS

The brief intervention (named iPAWS) will be an integration of evidence-based brief interventions for AYA SU (e.g. MET-CBT) and acute pain coping (CBT). The intervention is brief, readily accessible, developmentally tailored, applicable to single and poly-SU and scalable to other acutely painful procedures to meet the need for effective, accessible, and scalable SU interventions at key entry points of clinical care.

Educational Materials

Participants will be given a digital copy of a brochure from the American Dental Association on "Wisdom Teeth Management" (included in attachments). The investigator will also mail the participant a hard copy of the brochure, if requested.

Primary outcome measure

  • Number of participants who complete the active treatment phase (feasibility) [ Time Frame: End of active treatment phase (6 weeks) ]
  • Number of participants who rate their treatment experience in the "satisfactory" or "highly satisfactory" range on the Client Satisfaction Questionnaire (Acceptability) [ Time Frame: End of active treatment phase (6 weeks) ]

Central Contacts and Locations

Central contacts

Melissa Pielech, PhD

401-863-6583melissa_pielech@brown.edu

Kristin Rogers, MS

401-863-6463kristin_rogers@brown.edu

Locations

Brown University Center for Alcohol and Addiction Studies

Recruiting

Providence, Rhode Island, United States, 02903

More Information

Sponsor

Brown University

Last update posted

Jul 28, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-20. This information was provided to ClinicalTrials.gov by Brown University on 2026-07-28.