Pain, PostoperativeiPAWSNCT07731295
iPAWS: Improving Pain Management After Wisdom Tooth Extraction Surgery
A study testing iPAWS and Educational Materials in people with Pain, Postoperative and Substance Use, run by Brown University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Substance Use
- What is being tested?
- iPAWS and Educational Materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2026to 31 Dec 2026
- 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 15 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- N/A
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 Center for Alcohol and Addiction Studies
Providence, Rhode Island, 02903
About this study
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
- Being tested
- iPAWS, Educational Materials
- Medical subject headings
- Pain, Postoperative, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iPAWSBehavioural
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 MaterialsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| iPAWS Intervention | Experimental | Participants in the experimental condition will receive standard practice educational materials and the iPAWS self-guided, digital intervention. Receives: Behavioral: iPAWS; Other: Educational Materials |
| Educational Materials | Active comparator | Participants in the control condition will receive standard practice educational materials (i.e., in the form of a brochure). Receives: Other: Educational Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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%.
Measured: End of active treatment phase (6 weeks)
Secondary outcomes (6)
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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)
Measured: Last 3 weeks of active treatment phase (weeks 4-6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start29 Jun 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 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
- NCT07731295
- Sponsor's protocol ID
- STUDY00000662
- Other IDs
- 1K23DA053411
- Acronym
- iPAWS
- Status last verified
- May 2026
- First submitted
- 25 Jun 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iPAWS: Improving Pain Management After Wisdom Tooth Extraction Surgery
- ClinicalTrials.gov ID
- NCT07731295
- Acronym / sponsor ID
- iPAWS / STUDY00000662
- Conditions
- Pain, Postoperative, Substance Use
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 29 Jun 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Jul 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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iPAWS Intervention | Experimental | Behavioral: iPAWS, Other: Educational MaterialsParticipants in the experimental condition will receive standard practice educational materials and the iPAWS self-guided, digital intervention. |
| Educational Materials | Active comparator | Other: Educational MaterialsParticipants in the control condition will receive standard practice educational materials (i.e., in the form of a brochure). |
Who may qualify
- Ages
- 15 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| iPAWSThe 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. | Behavioural | iPAWS Intervention |
| Educational MaterialsParticipants 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. | Other | Educational Materials, iPAWS Intervention |
Primary outcome
Number of participants who complete the active treatment phase (feasibility)
Time frame: End of active treatment phase (6 weeks)
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%.
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)
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%.
6 secondary outcomes
Number of cannabis use days
Time frame: Last 3 weeks of active treatment phase (weeks 4-6)
Pain intensity
Time frame: Last 3 weeks of active treatment phase (weeks 4-6)
Substance use craving
Time frame: Last 3 weeks of active treatment phase (weeks 4-6)
Abstinent days
Time frame: Last 3 weeks of active treatment phase (weeks 4-6)
Pain intereference
Time frame: Last 3 weeks of active treatment phase (weeks 4-6)
Pain coping strategies
Time frame: Last 3 weeks of active treatment phase (weeks 4-6)
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 28 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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 iPAWS and Educational Materials in people with Pain, Postoperative and Substance Use, 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 6 inclusion and 1 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 28 Jul 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 Melissa Pielech, PhD (401-863-6583, melissa_pielech@brown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who complete the active treatment phase (feasibility) (time frame: End of active treatment phase (6 weeks)). 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 28 Jul 2026.