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Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia

NCT06281756 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2025-11-10

No results posted yet for this study

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

Interventions

DRUG

Trazodone

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

OTHER

Placebo

Non-remitting subjects will receive placebo for 8 weeks

BEHAVIORAL

Cognitive Behavioral Treatment for Insomnia (CBT-I)

Subjects will receive therapy for 8 weeks

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Milton S. Hershey Medical Center

    lead OTHER

Principal Investigators

  • Alexandros Vgontzas, MD · Professor, Psychiatry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-20
Primary Completion
2027-11-30
Completion
2028-05-31
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06281756 on ClinicalTrials.gov