Discontinuation of Hypnotics in Older Veterans (SWITCH)

November 8, 2024 updated by: VA Office of Research and Development

The Efficacy of Masked Tapering on Discontinuation of Hypnotics in Older Veterans

Sleeping medications, called hypnotics, are often prescribed for insomnia. About one-quarter of Veterans use hypnotics (or bedtime alcohol). Older patients who use hypnotics fall more often and have worse memory than those who do not use them. Stopping hypnotics often reverses these problems. The Department of Veterans Affairs (VA) is trying to reduce hypnotic use among older adults. Currently, there are two main treatments to help patients stop using hypnotics. The first treatment involves a slow decrease in the daily dose until the hypnotic is ultimately discontinued. For safety, the process of decreasing the daily dose is usually supervised by a physician. The second is a treatment for insomnia called cognitive behavioral therapy for insomnia (CBTI).

This study will compare a novel hypnotic tapering method to the usual tapering method offered to older Veterans. The purpose of the study is to determine if the novel tapering method is more effective than the usual tapering method, both in terms of hypnotic discontinuation and improvement in insomnia severity.

Participants will be recruited from among Veterans 55 years and older who receive care from one VA Healthcare System. Following a baseline assessment, participants will be randomly assigned to one of the two 8-week treatment groups (66 participants per group). Each treatment group will receive CBTI, however, one group will receive the novel tapering program and the other group the usual tapering program. Follow-up assessments will be conducted at post-treatment and at 6-months after completion of the treatment.

If the novel tapering program is effective, it will represent a treatment option that can be offered to older Veterans who want to discontinue hypnotics. This tapering program could help VA healthcare providers adhere to clinical guidelines that recommend benzodiazepine discontinuation among older adults. A reduction in chronic hypnotic use may in turn reduce the risk of falls and hip fractures, which ultimately may improve the health and quality of life of older Veterans who receive healthcare at the VA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hypnotics such as benzodiazepines and benzodiazepine receptor agonists are often prescribed for insomnia. Among Veterans attending outpatient clinics, approximately one-quarter use hypnotics (or bedtime alcohol). Hypnotics use is associated with an increased risk of falls and worse cognition in older adults. Discontinuing hypnotics often attenuates or reverses these negative effects, and the Department of Veterans Affairs (VA) has initiatives to reduce hypnotic use among older adults. Current discontinuation strategies focus on tapering off the hypnotic and/or treating insomnia symptoms. Common strategies include supervised gradual taper (SGT), cognitive behavioral therapy targeting hypnotic withdrawal (CBT-HW), cognitive behavioral therapy for insomnia (CBTI), and combination therapy (SGT+CBTI). Yet up to 40% of patients eventually resume use of hypnotics with these strategies, suggesting that other mechanisms need to be targeted to achieve and sustain high rates of non-use.

Objectives: 1) To assess the efficacy of a novel taper plus cognitive behavioral therapy-augmented program on hypnotic discontinuation among older Veterans, 2) to determine the impact of the the novel taper intervention on insomnia severity, 3) to assess the impact of the novel taper intervention on participants' beliefs and expectancies for using hypnotics to improve sleep quality and daytime function, and 4) to assess the efficacy of the novel taper intervention on balance and cognition.

To achieve these objectives, we propose to conduct a randomized clinical trial in older Veterans recruited from a single VA site. Veterans will undergo a 3-step screening process (letter with opt-out card, telephone screen, and in-person screen). Eligible participants (N = 132) will be randomized to 8 weeks of the novel taper intervention (CBTI+taper method A) or CBTI+taper method B. Follow-up assessments will be conducted at post-treatment and 6-months. Key 6-month outcomes will include hypnotic discontinuation and use (measured objectively through lab testing and medical record review/state prescription monitoring database query, and subjectively through sleep diary), insomnia severity, beliefs and expectations about hypnotics, balance, and cognition.

This hypnotic discontinuation program could be an important tool to help older Veterans who want to discontinue hypnotics to achieve this goal.

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • West Los Angeles, California, United States, 90073-1003
        • VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Age >= 55 years

  • Use of lorazepam, alprazolam, temazepam, clonazepam, and/or zolpidem for current or prior insomnia symptoms 2 or more nights per week for at least 3 months
  • Current or prior insomnia symptoms
  • Available to attend weekly in-person or video sessions over 9 weeks

Exclusion Criteria:

High risk for complications in outpatient hypnotic discontinuation program:

  • Seizure disorder
  • Supratherapeutic/high baseline hypnotic dose (> diazepam-equivalent of 8 mg/night). Note that for individuals on > 1 of the targeted hypnotics, total baseline dose in diazepam-equivalents will be calculated & if > 8 mg/night, individual will be excluded.
  • High risk of complicated withdrawal; benzodiazepine intoxication or current or past symptoms of complicated benzodiazepine/alcohol withdrawal (e.g., seizure, delirium at baseline)
  • Polydrug use (e.g., chronic high dose opioids)
  • Unable to keep study medications in secure location
  • Evidence of prescription fraud (e.g., multiple prescriptions for same drug filled at VA and non-VA pharmacies, diversion)

Discontinuation of hypnotic not appropriate:

  • Study-targeted hypnotic used to treat another clinical condition (e.g., Rapid Eye Movement sleep behavior disorder)
  • Not willing to begin hypnotic discontinuation program

Poor candidate for CBTI:

  • Presence of bipolar disorder
  • Cognitive impairment (e.g., Mini-Mental State Examination < 24)
  • Sleep/wake difficulty is better explained by another sleep disorder such as restless legs syndrome, narcolepsy, insufficient sleep syndrome, or circadian rhythm sleep-wake disorders
  • Untreated sleep-disordered breathing defined as:

Apnea-hypopnea index (AHI) > 30 AHI between 15 and 30 and daytime sleepiness (Epworth Sleepiness Scale > 10)

  • Medically/psychiatrically unstable (e.g., recent major hospitalization or planned major surgery during the study; psychosis, suicidal, active alcohol/substance abuse based on history and medical records)
  • Unstable housing situation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CBTI plus Taper method A
Participants in this arm will receive Cognitive Behavioral Therapy for Insomnia (CBTI) plus the novel hypnotic tapering method.
Behavioral: CBTI plus taper method A
This intervention includes CBTI plus the novel hypnotic tapering method.
Active Comparator: CBTI plus Taper method B
Participants in this arm will receive Cognitive Behavioral Therapy for Insomnia (CBTI) plus the usual tapering method used by the VA.
Behavioral: CBTI plus taper method B
This intervention includes CBTI plus the usual hypnotic tapering method used by the VA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of Hypnotic Discontinuation
Time Frame: 6 months after treatment ends (which is an average of 8 months from randomization)
The percentage of participants who had stopped taking a benzodiazepine or z-drug at follow-up. This outcome was measured with 7-day self-reported medication logs.
6 months after treatment ends (which is an average of 8 months from randomization)
Insomnia Severity Index Score
Time Frame: 6 months after treatment ends (which is an average of 8 months from randomization)

Mean score on Insomnia Severity Index. This 7-item scale measures self-reported severity of insomnia symptoms.

Total score ranges from 0 to 28, with higher scores indicating greater insomnia severity.
6 months after treatment ends (which is an average of 8 months from randomization)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Constance H Fung, MD MSHS, VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2018

Primary Completion (Actual)

November 27, 2023

Study Completion (Actual)

November 27, 2023

Study Registration Dates

First Submitted

April 18, 2018

First Submitted That Met QC Criteria

April 18, 2018

First Posted (Actual)

April 27, 2018

Study Record Updates

Last Update Posted (Estimated)

November 14, 2024

Last Update Submitted That Met QC Criteria

November 8, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IIR 17-234

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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