Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain

Part of paid clinical trials in Tampa, Florida.

Sponsor
University of South Florida
Study ID
NCT06345872
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • CBT-I — BEHAVIORAL
    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.
  • Treatment as usual — BEHAVIORAL
    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.
  • Tapered Withdrawal — OTHER
    Individualized gradual tapered withdrawal following CDC guidelines, additional check-ins and motivational interviewing with a therapist.

Study Details

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.

Key Dates

Start date
Dec 11, 2024
Status verified
Apr 2026
Primary completion
Jan 1, 2028
Completion
Jul 1, 2028

Study Design

Enrollment
165 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental
    8 weeks of online CBT-I (1 session/week for 1 hour), followed by tapered withdrawal and motivational interviewing and check-ins.
  • Other: Treatment as usual
    Continuation of standard treatment for sleep and pain for 8 weeks, followed by tapered withdrawal and motivational interviewing and check-ins.

Primary Outcome Measure

Change in Insomnia Severity Index [ Time Frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of South FloridaTampaFlorida33612
Christina S McCrae, PhD
[email protected]
813-974-1804
Britani Holland, PhD
[email protected]
8139741804

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By research site
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