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Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain

NCT06345872 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2026-04-21

No results posted yet for this study

Summary

The goal of this study is to test two behavioral interventions for chronic insomnia in individuals with chronic pain and use prescribed opioid medication to treat their chronic pain.

Conditions

Interventions

BEHAVIORAL

CBT-I

Includes 8 weekly sessions of CBT-I and 2 bi-monthly boosters. Each session is to be completed individually by the participant in a single sitting (less than 45 mins). Each session should be completed in 7 days with next session released only after prior one completed.

BEHAVIORAL

Treatment as usual

Includes 8 weekly sessions of standard treatment and 2 bi-monthly boosters. Each session is to be completed individually by the participant in a single sitting (less than 45 mins). Each session should be completed in 7 days with next session released only after prior one completed.

OTHER

Tapered Withdrawal

Individualized gradual tapered withdrawal following CDC guidelines, additional check-ins and motivational interviewing with a therapist.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • University of South Florida

    lead OTHER

Principal Investigators

  • Christina S McCrae, PhD · University of South Florida

  • Britani Holland, PhD · University of South Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-11
Primary Completion
2028-01-01
Completion
2028-07-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT06345872 on ClinicalTrials.gov