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Feasibility and Acceptability of OLP-EXP in Chronic Pain

NCT07735520 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2026-07-30

No results posted yet for this study

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.

Conditions

  • Temporomandibular Disorders (TMD)

Interventions

OTHER

OLP-EXP

Expectation optimization addressing benefit, personal control, and coping expectations, plus transparent daily OLP pills for 6 weeks and weekly boosters.

DIETARY_SUPPLEMENT

OLP

Open-label placebo pills. The placebo pills in this study are empty capsules without any ingredients inside. The capsules are made of microcrystalline cellulose.

BEHAVIORAL

EXP

Expectation optimization addressing personal-control and coping expectations associated with chronic pain in general, plus weekly boosters.

Sponsors & Collaborators

  • University of Maryland, Baltimore

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-07-01
Primary Completion
2028-12-31
Completion
2029-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07735520 on ClinicalTrials.gov