Feasibility and Acceptability of OLP-EXP in Chronic Pain
Not yet recruitingNot applicableNCT07735520
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The primary objective is to determine the feasibility of delivering OLP-EXP, EXP only, and OLP only over 6 weeks to adults with chronic TMD. The trial will be considered feasible for progression planning when the 6-week retention rate is at least 80% in each arm and average OLP pill adherence is at least 80% of prescribed days in each OLP arm. Primary hypothesis: Each intervention arm will meet the prespecified 6-week retention benchmark, and each OLP arm will meet the prespecified pill-adherence benchmark. The secondary objectives are: 1. To evaluate acceptability of each intervention using the TFA measurement and semi-structured interviews. 2. To assess the feasibility of collecting daily EMA, continuous actigraphy, weekly questionnaires, and 3-, 6-, and 12-month follow-up assessments. 3. To identify intervention barriers, facilitators, perceived benefits, burden, ethical concerns, and recommendations for a future fully powered efficacy trial. 4. To estimate variability, missingness, and measure reliability needed to select outcomes and design a future trial.
Study details
- Official title
- Evaluating the Feasibility and Acceptability of Expectation-optimized Open-label Placebo as an Adjuvant Treatment for Chronic Pain
- Conditions
- Temporomandibular Disorders (TMD)
- Interventions
- Other: OLP-EXP
- Dietary supplement: OLP
- Behavioral: EXP
- Sponsor
- University of Maryland, Baltimore
- Start date
- 2027-07-01
- Primary completion
- 2028-12-31
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * English speaking (written and spoken) * Age between 18 and 65 years * Confirmed TMD for more than 3 months * Grade II or above on the Graded Chronic Pain Scale Exclusion Criteria: * Personal (or family first degree) history of mania, schizophrenia, or other psychoses * Severe psychiatric conditions require medication (e.g. schizophrenia, bipolar disorders, autism) or hospitalization within the last 3 years. * Lifetime alcohol/drug dependence and alcohol/drug abuse in past one year * Pregnancy/Breastfeeding * Currently participating in another clinical trial
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07735520