Clinical Research Directory

Feasibility and Acceptability of OLP-EXP in Chronic Pain

Sponsor: University of Maryland, Baltimore

Summary

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.

Official title: Evaluating the Feasibility and Acceptability of Expectation-optimized Open-label Placebo as an Adjuvant Treatment for Chronic Pain

Key Details

Conditions

Interventions