Solriamfetol and CBT-I in Patients With Insomnia Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-31

Study Completion Date

2026-04-30

Brief Summary

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Medication is FDA approved. The objective of this project is to test the efficacy of solriamfetol for treating insomnia (alone and in combination with Cognitive Behavioral Therapy for Insomnia \[CBT-I\]). Ultimately, this study will test whether wake extension (regardless of how it is achieved) will consolidate sleep and improve sleep continuity.

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Detailed Description

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The current proposal is for a one-year study to investigate whether solriamfetol can improve sleep continuity and daytime performance, alone and in combination with Cognitive Behavioral Therapy for Insomnia. It is expected (given a common mechanism \[wake extension\]) that both Cognitive Behavioral Therapy for Insomnia and treatment with solriamfetol will improve sleep continuity, and that such effects will potentially be additive.

Conditions

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Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

A 2x2 mixed model design. The two factors will be 1) treatment (+/- solriamfetol and +/- CBT-I) and 2) Time (pre-post assessment, with additional follow-up data).

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Blinding only applies to the medication arm. The randomization schedule was developed by our statistician and sent directly to research pharmacy for implementation.

The four arms are as follows:

1. Solriamfetol + CBT-I
2. Placebo + CBT-I
3. Solriamfetol Only
4. Placebo Only

All conditions engage in monitoring and assessment.

Study Groups

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Solriamfetol+ CBT-I

Group Type EXPERIMENTAL

Solriamfetol 75 MG

Intervention Type DRUG

Solriamfetol (trade name Sunosi), is a norepinephrine-dopamine reuptake inhibitor available in 75mg and 150mg tablets for oral administration during the day. Solriamfetol's primary indication is to treat excessive daytime sleepiness (EDS) in patients diagnosed with obstructive sleep apnea or Narcolepsy. It binds to the dopamine and the norepinephrine transporters with affinities (Ki) of 14.2 μM and 3.7 μM, respectively),does not undergo significant metabolism in humans, and has a Tmax of \~2 hours (range 1.25-3.0 hours) and a T1/2 of \~7.1 hours.

Cognitive Behavioral Therapy for Insomnia (CBT-I)

Intervention Type BEHAVIORAL

Treatment will be conducted via a HIPAA compliant video link (Zoom). Sessions 1-8 will follow our published protocol (published in 2005 by Springer).

Each session will be conducted individually and have a singular focus per session.

All sessions following the delivery of sleep restriction therapy \& stimulus control instructions (post Session 2) will include, as needed, management of non-adherence and/or time-in-bed titration.

Solriamfetol Only

Group Type EXPERIMENTAL

Solriamfetol 75 MG

Intervention Type DRUG

Solriamfetol (trade name Sunosi), is a norepinephrine-dopamine reuptake inhibitor available in 75mg and 150mg tablets for oral administration during the day. Solriamfetol's primary indication is to treat excessive daytime sleepiness (EDS) in patients diagnosed with obstructive sleep apnea or Narcolepsy. It binds to the dopamine and the norepinephrine transporters with affinities (Ki) of 14.2 μM and 3.7 μM, respectively),does not undergo significant metabolism in humans, and has a Tmax of \~2 hours (range 1.25-3.0 hours) and a T1/2 of \~7.1 hours.

Monitoring

Intervention Type OTHER

No CBT-I will be administered, however, the tracking system used for CBT-I will be used for all subject conditions. This includes a sleep disorder symptoms screener, the administration of several questionnaires on a weekly basis, and the administration of daily sleep diaries online or via iPhone. Note: it is a common effect that regular monitoring of this type produces perceived clinical benefit.

Placebo + CBT-I

Group Type ACTIVE_COMPARATOR

Cognitive Behavioral Therapy for Insomnia (CBT-I)

Intervention Type BEHAVIORAL

Treatment will be conducted via a HIPAA compliant video link (Zoom). Sessions 1-8 will follow our published protocol (published in 2005 by Springer).

Each session will be conducted individually and have a singular focus per session.

All sessions following the delivery of sleep restriction therapy \& stimulus control instructions (post Session 2) will include, as needed, management of non-adherence and/or time-in-bed titration.

Placebo

Intervention Type OTHER

Placebo, identical in appearance to the active drug.

Placebo Only

Group Type PLACEBO_COMPARATOR

Monitoring

Intervention Type OTHER

No CBT-I will be administered, however, the tracking system used for CBT-I will be used for all subject conditions. This includes a sleep disorder symptoms screener, the administration of several questionnaires on a weekly basis, and the administration of daily sleep diaries online or via iPhone. Note: it is a common effect that regular monitoring of this type produces perceived clinical benefit.

Placebo

Intervention Type OTHER

Placebo, identical in appearance to the active drug.

Interventions

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Solriamfetol 75 MG

Solriamfetol (trade name Sunosi), is a norepinephrine-dopamine reuptake inhibitor available in 75mg and 150mg tablets for oral administration during the day. Solriamfetol's primary indication is to treat excessive daytime sleepiness (EDS) in patients diagnosed with obstructive sleep apnea or Narcolepsy. It binds to the dopamine and the norepinephrine transporters with affinities (Ki) of 14.2 μM and 3.7 μM, respectively),does not undergo significant metabolism in humans, and has a Tmax of \~2 hours (range 1.25-3.0 hours) and a T1/2 of \~7.1 hours.

Intervention Type DRUG

Cognitive Behavioral Therapy for Insomnia (CBT-I)

Treatment will be conducted via a HIPAA compliant video link (Zoom). Sessions 1-8 will follow our published protocol (published in 2005 by Springer).

Each session will be conducted individually and have a singular focus per session.

All sessions following the delivery of sleep restriction therapy \& stimulus control instructions (post Session 2) will include, as needed, management of non-adherence and/or time-in-bed titration.

Intervention Type BEHAVIORAL

Monitoring

No CBT-I will be administered, however, the tracking system used for CBT-I will be used for all subject conditions. This includes a sleep disorder symptoms screener, the administration of several questionnaires on a weekly basis, and the administration of daily sleep diaries online or via iPhone. Note: it is a common effect that regular monitoring of this type produces perceived clinical benefit.

Intervention Type OTHER

Placebo

Placebo, identical in appearance to the active drug.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

• Participants will meet the diagnostic criteria for Insomnia Disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5).

In addition, the complaint of disturbed sleep will meet the following criteria:

* ≥ 30 minutes to fall asleep (SL) and/or ≥ 2 awakenings per night of ≥ 15 minutes duration and/or wake after sleep onset (WASO) time of ≥ 30 minutes where total sleep time (TST) did not exceed 6 hours (unless sleep efficiency \[SE\] is ≤ 80%).
* The problem is present for \> 3 nights per week.
* The problem duration exceeds ≥ 6 months.
* The complaint of impaired daytime function must include, although not limited to, the report of daytime fatigue, sleepiness, or both.
* Preferred regular sleep phase between 10:00 PM and 8:00 AM
* Must garner physician's assent from their primary care clinician

Exclusion Criteria

* Use of medication expressly for the purpose of falling or staying asleep (e.g., trazodone/ desyrel, melatonin, Tylenol PM, Nyquil, Benadryl).
* Night shift work
* Compromised renal function
* Major Coronary Artery Disease and/or uncontrolled (with meds) Hypertension
* Planning to become pregnant, pregnant, and/or breastfeeding
* Unstable medical or psychiatric illness
* Symptoms suggestive of sleep disorders other than insomnia
* Polysomnographic data indicating sleep disorders other than insomnia
* Evidence of active illicit substance use, abuse, or dependence
* Use of CNS active medications that are for treatment of insomnia or are thought to have caused insomnia as a side effect
* Inadequate language comprehension
* Current or past experience with CBT-I
* No access to the computers, I-Pads, or the internet

Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No