iPAWS: Improving Pain Management After Wisdom Tooth Extraction Surgery (iPAWS)

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative; Substance Use
• Intervention / Treatment: Behavioral: iPAWS; Other: Educational Materials

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristin Rogers, MS; Phone Number: 401-863-6463; Email: kristin_rogers@brown.edu
• Study Contact Backup: Name: Melissa Pielech, PhD; Phone Number: 401-863-6583; Email: melissa_pielech@brown.edu

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Recruiting
      • Brown University Center for Alcohol and Addiction Studies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: iPAWS Intervention; Participants in the experimental condition will receive standard practice educational materials and the iPAWS self-guided, digital intervention.	Behavioral: 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.; Other: 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.
Active Comparator: Educational Materials; Participants in the control condition will receive standard practice educational materials (i.e., in the form of a brochure).	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who complete the active treatment phase (feasibility)	The number of participants who complete the active treatment phase will determine feasibility. The treatment will be considered feasible if the number of participants who complete treatment is ≥ 70%.	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)	The Client Satisfaction Questionnaire (CSQ-8) which ranges in scores from 8 to 32 will determine acceptability. Higher scores indicate higher satisfaction (i.e. better outcomes). Treatment will be considered acceptable if the number and percentage of participants who rate their experience either "satisfactory" or "highly satisfactory is ≥ 80%.	End of active treatment phase (6 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of cannabis use days	Number of days that participants consumed cannabis over the last 3 weeks (weeks 4-6 of treatment) will be measured by the Timeline Followback Interview.	Last 3 weeks of active treatment phase (weeks 4-6)
Pain intensity	Average pain intensity is assessed during daily Ecological Momentary Assessments using the Numerical Rating Scale (NRS) . This is assessed on a scale from 0 (no pain) to 10 (most pain possible). Minimum value= 0 and maximum value=10. Higher scores indicate higher levels of pain (i.e. worse outcome). Analysis will examine average pain levels after treatment (weeks 4-6).	Last 3 weeks of active treatment phase (weeks 4-6)
Substance use craving	Substance use craving is measured during daily Ecological Momentary Assessments using an item validated in past work: "How strong is your urge to use substances right now? This includes marijuana, alcohol, nicotine, and other drugs." This is assessed on scale from 0 (no urge) to 10 (strongest urge ever). Minimum value= 0 and maximum value=10 and higher scores indicate higher levels of craving (i.e. worse outcomes). Analysis will examine responses to this item after treatment (weeks 4-6).	Last 3 weeks of active treatment phase (weeks 4-6)
Abstinent days	Abstinent days (proportion of days on which no cannabis use is reported) during the last 3 weeks (treatment weeks 4-6). The analysis will control for baseline (defined as proportion of abstinent days in the two weeks preceding the treatment).	Last 3 weeks of active treatment phase (weeks 4-6)
Pain intereference	Pain interference is assessed during daily Ecological Momentary Assessments using 1 item: "How much is physical pain getting in the way of doing regular daily activities right now, including eating and drinking?" This is assessed on a scale from 0 (not at all ) to 10 (extremely). Minimum value= 0 and maximum value=10. Higher scores indicate higher levels of pain interference (i.e. worse outcome). Analysis will examine ratings of pain interference after treatment (weeks 4-6).	Last 3 weeks of active treatment phase (weeks 4-6)
Pain coping strategies	Utilization of non-pharmacological pain coping skills is assessed during daily Ecological Momentary Assessments using a checklist of psychosocial (n=10 items) and physical coping strategies (n=10 items). Responses are binary (yes or no). The minimum value for each type of skill is 0 and the maximum value is 10. Higher scores reflect higher utilization of these skills (i.e. better outcomes). Analysis will examine utilization of non-pharmacological pain coping skills after treatment (weeks 4-6)	Last 3 weeks of active treatment phase (weeks 4-6)

Collaborators and Investigators

• Sponsor: Brown University
• Collaborators: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 25, 2026
• First Submitted That Met QC Criteria: July 24, 2026
• First Posted (Actual): July 28, 2026

Study Record Updates

• Last Update Posted (Actual): July 28, 2026
• Last Update Submitted That Met QC Criteria: July 24, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Mental Disorders; Postoperative Complications; Pathologic Processes; Chemically-Induced Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Substance-Related Disorders
• Other Study ID Numbers: STUDY00000662; 1K23DA053411 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No