Recruiting
Early Phase 1

CBT & Trazodone

Sponsor:

Milton S. Hershey Medical Center

Code:

NCT06281756

Conditions

Insomnia

Insomnia Chronic

Insomnia, Primary

Blood Pressure

Blood Pressure, High

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cognitive Behavioral Treatment for Insomnia (CBT-I)

Trazodone

Placebo

Study Details

Brief summary:

Individuals who have insomnia with short sleep duration (ISS) differ from individuals who have insomnia with normal sleep duration (INS) in terms of health risks (i.e., hypertension) and treatment response. This study will examine whether patients with ISS and INS demonstrate a differential response to two common insomnia treatments. One is behavioral, Cognitive Behavioral Therapy for Insomnia (CBT-I). The other is a widely prescribed, non-habit-forming medication, trazodone used at a low dose. The investigators' findings could lead to evidence-based treatment guidelines that help clinicians more effectively match treatments to insomnia patients and reduce associated health problems.

Conditions

Insomnia

Insomnia Chronic

Insomnia, Primary

Blood Pressure

Blood Pressure, High

Study ID

NCT06281756

Start date

Mar 20, 2024

Status verified date

Nov, 2025

Completion date

May 31, 2028

Anticipated

Primary completion date

Nov 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 18 or older
  • Able to read and effectively communicate in English at the United States sites or able to read and effectively communicate in English or French at the Canadian site.
  • Meets criteria for chronic insomnia
  • Body Mass Index (BMI) 18.5 kg/m2 and higher

Exclusion Criteria:

  • Age < 18
  • Unable to read and effectively communicate in English at the United States sites or able to read and effectively communicate in English or French at the Canadian site.
  • Unwilling to share email address/cell phone number to accept survey links.
  • Life time diagnosis of psychotic or bipolar disorder
  • History of severe apnea or an Apnea Hypopnea Index (AHI) ≥15 that is not currently treated with Positive Airway Pressure (PAP) therapy, an oral device or an implanted device, or was not treated with surgery or weight loss.
  • Started new or changed treatment for sleep apnea in the past three months
  • Does not meet criteria for chronic insomnia
  • Meets criteria for narcolepsy or hypersomnia disorder
  • Meets criteria for circadian rhythm disorder (including night shift work)
  • Unstable medical conditions that would make participation unsafe or unfeasible
  • Falls resulting in hospitalization, significant injury or fracture within past 12 months
  • 2 hospitalizations or emergency room visits within past 12 months for chronic conditions
  • Active chemotherapy or radiation therapy for cancer
  • Lifetime diagnoses/treatment of chronic renal failure, hepatic insufficiency, chronic heart failure
  • Does not agree to refrain from other treatments for insomnia beyond what is offered in this study
  • BMI less than 18.5
  • Substance abuse or dependence in the past 12 months
  • Current use of prescription or over the counter medications taken for sleep greater than 2 times per week
  • Current use of systemic corticosteroids or opiate medications
  • Current pregnancy or breastfeeding; plans to get pregnant or unwillingness to use birth control for the length of the study
  • Current use of medications contraindicated with trazodone
  • Sleep apnea or periodic leg movement disorder as determined by sleep study
  • Blood Pressure levels defined as seated SBP greater than 180 or DBP greater than 110 mmHg
  • EKG corrected QT interval greater than or equal to 500 ms

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with placebo

Subjects with insomnia treated with Cognitive Behavior Treatment for Insomnia (CBT-I) for 8 weeks, then non-remitting subjects received placebo for 8 weeks.

active comparator: Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with Trazodone

Subjects with insomnia treated with Cognitive Behavior Treatment for Insomnia (CBT-I) for 8 weeks, then non-remitting subjects received trazodone for 8 weeks.

Interventions

Cognitive Behavioral Treatment for Insomnia (CBT-I)

Subjects will receive therapy for 8 weeks

Trazodone

Non-remitting subjects will receive Trazodone (dosage) for 8 weeks

Placebo

Non-remitting subjects will receive placebo for 8 weeks

Primary outcome measure

  • Remission of insomnia symptoms following Cognitive Behavioral Therapy for Insomnia (CBT-I) [ Time Frame: 9 weeks ]
  • Remission of insomnia symptoms following trazodone/placebo Randomized Controlled Trial (RCT) [ Time Frame: 9 weeks ]
  • Remission of insomnia symptoms 6 months following completion of CBT-I Or RCT Treatment [ Time Frame: 35 weeks ]

Central Contacts and Locations

Central contacts

Carrie Criley

717-531-4123ccriley@pennstatehealth.psu.edu

Locations

National Jewish Health

Recruiting

Denver, Colorado, United States, 80206-2761

Contacts

Roxane Horberg

303-270-2850horbergr@njhealth.org

Rachel Johnson

303 398-1058johnsonr@njhealth.org

Penn State University

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Carrie Criley

717-531-4123ccriley@pennstatehealth.psu.edu

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213-3203

Contacts

Laurie Brar

412-723-7998brarlk@upmc.edu

Université Laval

Recruiting

Québec, Quebec, Canada, G1V 0A6

Contacts

Manon Lamy

418 656-2131manon.lamy@psy.ulaval.ca

More Information

Sponsor

Milton S. Hershey Medical Center

Last update posted

Nov 10, 2025

Last verified

Nov, 2025

Keywords

  • sleep
  • sleep disorder
  • insomnia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-14. This information was provided to ClinicalTrials.gov by Milton S. Hershey Medical Center on 2025-11-10. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.