Trial intelligence / Profile preview

Combined Behavioral/Pharmacological Therapy for Insomnia

NCT00044629Phase 2

Key facts

Status
Completed
Start
Sep 2001
Countries
1
Sponsor
Duke University
Modality
Small Molecules
Conditions
Insomnia
01

Overview

Phase 2, randomised, double-blind trial of zolpidem in Insomnia (3 arms), sponsored by Duke University. Started Sep 2001; status: completed.

02

Design

3 arms
Study design
RandomizedDouble-blind
  • CBT + Ambien

    Cognitive Behavioral Therapy plus zolpidem tartrate

  • CBT + Placebo

    Cognitive Behavioral Therapy plus placebo

  • CBT alone

    Cognitive Behavioral Therapy alone

03

Who it enrols

Adults aged 21-75 with chronic insomnia (>6 months) and poor sleep hygiene, excluding those with major psychiatric disorders, sleep apnea, or dependence on hypnotics.

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