Health Trialsby

Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain

ConditionsChronic Pain Chronic Insomnia Opioid Use

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of South Florida

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18+ yrs

willing to be randomized,

can read/understand English

diagnosed with chronic widespread pain and insomnia (as described below)

Disqualifiers

unable to provide informed consent

cognitive impairment (MMSE <26)

sleep disorder other than insomnia [i.e., sleep apnea (apnea/hypopnea index, AHI >15)

Periodic Limb Movement Disorder (myoclonus arousals per hour >15)]

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

165 Participants

are divided into 2 treatment groups

Group A: ExperimentalExperimental treatment 2 interventions

Group B: Treatment as usualOther 2 interventions

Trial outcomes

Primary outcomes

1

Change in Insomnia Severity Index

Insomnia severity; score range 0-28 (low severity - high severity)

Time frame

Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

2

Change in Pain Intensity - Daily Electronic Sleep Diaries

Daily electronic dairies will record pain unpleasantness; range: 0-100 (none- most unpleasantness)

Time frame

Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

3

Change in Wake After Sleep Onset - Daily Electronic Sleep Diaries

Daily electronic dairies will record wake after sleep onset (number of minutes)

Time frame

Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

4

Change in Sleep Onset Latency- Daily Electronic Sleep Diaries

Daily electronic dairies will record sleep onset latency (number of minutes)

Time frame

Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

Secondary outcomes

1

Change in Objective Wake After Sleep Onset (Actigraph)

Wake after sleep onset via GENEActiv

Time frame

Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

2

Change in Objective Sleep Onset Latency (Actigraph)

Sleep Onset Latency via GENEActiv

Time frame

Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

3

Change in Objective Sleep Efficiency (Actigraph)

Sleep Efficiency via GENEActiv

Time frame

Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

4

Change in Neural Connectivity: Structural/Functional MRI/Diffusion Weighted Imaging

Assessment of brain connectivity

Time frame

Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

Other outcomes

1

Change in 36-Item Short Form Survey (SF-36)

Self-reported health; score range: low quality of life to high quality of life

Time frame

Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

2

Change in Depression (Beck Depression Inventory-II)

Depression severity; score range: 0-63 (normal - extreme depression)

Time frame

Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

3

Change in State-Trait Anxiety Inventory (STAI)

Trait and state anxiety; score range: 20-80 (low anxiety - high anxiety)

Time frame

Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

4

Medications/Substances Uses and Dosages

Non-opioid pain/sleep medication use and dosage, tobacco, caffeine, alcohol, marijuana via daily electronic diaries

Time frame

Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of South Florida

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov