Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain

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.

Change in Insomnia Severity Index

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

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

Change in Pain Intensity - Daily Electronic Sleep Diaries

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

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

Change in Wake After Sleep Onset - Daily Electronic Sleep Diaries

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

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

Change in Sleep Onset Latency- Daily Electronic Sleep Diaries

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

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

Change in Sleep Efficiency- Daily Electronic Sleep Diaries

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

Daily electronic dairies will record sleep efficiency

Change in Fatigue - Daily Electronic Sleep Diaries

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

Daily electronic dairies will record insomnia severity; range: 0-100 (no insomnia - most severe)

Change in Sleep and Pain Medication - Daily Electronic Sleep Diaries

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

Daily electronic dairies will record daily medication consumption)

Change in Perceived Stress Scale

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

Perception of stress; score range: 0-40 (low stress - high stress)

Change in Peripheral Arousal

Time frame: 5 mins at rest at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

Heart Rate Variability (as measured by Holter-Monitoring)

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

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

Assessment of neural plasticity

Change in Thermal Pain Response

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

Participants will undergo quantitative sensory testing using a contact thermode applied to the left plantar, VAS scale for pain ()-100)

Change in Opioid Use (Quantitative)

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

Change in opioid use assessed with quantitative urine opioid panel

Change in Opioid Use (Self-Report)

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

Change in opioid use assessed with daily electronic diaries

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.