Brown University Center for Alcohol and Addiction Studies
Providence, Rhode Island, 02903, United States
Location status: Recruiting
NCT Number: NCT07731295
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.
Interested in participating?
Request Info15 year–20 year
All sexes
Interventional
Not applicable
Providence, Rhode Island, 02903, United States
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
*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.
Exclusion criteria
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.
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.
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%.
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%.
Time frame: Last 3 weeks of active treatment phase (weeks 4-6)
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.
Time frame: Last 3 weeks of active treatment phase (weeks 4-6)
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).
Time frame: Last 3 weeks of active treatment phase (weeks 4-6)
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).
Time frame: Last 3 weeks of active treatment phase (weeks 4-6)
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).
Time frame: Last 3 weeks of active treatment phase (weeks 4-6)
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).
Time frame: Last 3 weeks of active treatment phase (weeks 4-6)
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)
Contact information is provided by the study sponsor or research team.
Kristin Rogers, MS
CONTACT
Melissa Pielech, PhD
CONTACT
Brown University
Other
Acronym: iPAWS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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