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Use of Blinded Tapering for Hypnotic Discontinuation

NCT04050176 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2025-02-24

No results posted yet for this study

Summary

The study will employ a randomized longitudinal clinical trial design to evaluate the relative efficacy of a blinded hypnotic tapering protocol when used in combination with therapist delivered Cognitive Behavioral Therapy for Insomnia (CBTI) for enhancing hypnotic discontinuation rates. A blinded SMT+CBTI intervention will be compared to open-label SMT+CBTI.

Conditions

  • Hypnotic Dependence Among Those With Insomnia

Interventions

BEHAVIORAL

Hypnotic Medication Open-Label Taper

Participants will have their soporific hypnotic medication dosage reduced by 25% every two weeks during a 10 week open-label tapering period.

BEHAVIORAL

Hypnotic Medication Blinded Taper

Participants will have their soporific hypnotic medication dosage reduced by 25% every two weeks during a 10 week blinded tapering period.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • National Jewish Health

    lead OTHER

Principal Investigators

  • Jack D Edinger, Ph.D. · National Jewish Health

  • Fredrick Wamboldt, M.D. · National Jewish Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-16
Primary Completion
2024-12-31
Completion
2026-06-30

Countries

  • United States

Study Locations

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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 NCT04050176 on ClinicalTrials.gov