Discontinuation of Hypnotics in Older Veterans

NCT03511209 | Completed Results DMC

• 1 other identifier: IIR 17-234
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Insomnia

Keywords

Sleep Initiation and Maintenance Disorders; Hypnotics and Sedatives

Outcome Measures

Primary Outcomes (2)

• Rates of Hypnotic Discontinuation

  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

  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)

Study Arms (2)

CBTI plus Taper method A

EXPERIMENTAL

Participants in this arm will receive Cognitive Behavioral Therapy for Insomnia (CBTI) plus the novel hypnotic tapering method.

Behavioral: CBTI plus taper method A

CBTI plus Taper method B

ACTIVE COMPARATOR

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

Interventions

CBTI plus taper method A BEHAVIORAL

This intervention includes CBTI plus the novel hypnotic tapering method.

CBTI plus Taper method A

CBTI plus taper method B BEHAVIORAL

This intervention includes CBTI plus the usual hypnotic tapering method used by the VA.

CBTI plus Taper method B

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073-1003, United States

Location

Related Publications (5)

• Fung CH, Martin JL, Alessi C, Dzierzewski JM, Cook IA, Moore A, Grinberg A, Zeidler M, Kierlin L. Hypnotic Discontinuation Using a Blinded (Masked) Tapering Approach: A Case Series. Front Psychiatry. 2019 Oct 24;10:717. doi: 10.3389/fpsyt.2019.00717. eCollection 2019.

  PMID: 31708806 BACKGROUND

• McCarthy M, Mak S, Kaufmann CN, Lum HD, Fung CH. Care coordination needs for deprescribing benzodiazepines and benzodiazepine receptor agonists. Res Social Adm Pharm. 2022 Apr;18(4):2691-2694. doi: 10.1016/j.sapharm.2021.06.025. Epub 2021 Jul 1.

  PMID: 34229951 RESULT

• Gutierrez L, Ghadimi S, Krall A, Hampson E, Grinberg AM, Moore AA, Dzierzewski JM, Alessi C, Martin JL, Fung CH. Posttraumatic Stress Disorder Risk and Benzodiazepine Dependence in Older Veterans with Insomnia Symptoms. Clin Gerontol. 2022 Mar-Apr;45(2):414-418. doi: 10.1080/07317115.2021.1954123. Epub 2021 Aug 4.

  PMID: 34346855 RESULT

• Ghadimi S, Grinberg A, Mitchell MN, Alessi C, Moore AA, Martin JL, Dzierzewski JM, Kelly M, Badr MS, Guzman A, Smith JP, Zeidler M, Fung CH. Sleep characteristics and use of multiple benzodiazepine receptor agonists in older adults. J Am Geriatr Soc. 2023 Dec;71(12):3924-3927. doi: 10.1111/jgs.18528. Epub 2023 Aug 1. No abstract available.

  PMID: 37526436 RESULT

• Fung CH, Alessi C, Martin JL, Josephson K, Kierlin L, Dzierzewski JM, Moore AA, Badr MS, Zeidler M, Kelly M, Smith JP, Cook IA, Der-Mcleod E, Ghadimi S, Naeem S, Partch L, Guzman A, Grinberg A, Mitchell M. Masked Taper With Behavioral Intervention for Discontinuation of Benzodiazepine Receptor Agonists: A Randomized Clinical Trial. JAMA Intern Med. 2024 Dec 1;184(12):1448-1456. doi: 10.1001/jamainternmed.2024.5020.

  PMID: 39374004 RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Constance H. Fung, MD, MSHS
• Organization: VA Greater Los Angeles Healthcare System

Constance.Fung@va.gov

818-891-7711

Study Officials

• Constance H Fung, MD MSHS

  VA Greater Los Angeles Healthcare System, West Los Angeles, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Only the participants and the outcome assessors will be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: April 27, 2018
• Study Start: December 10, 2018
• Primary Completion: November 27, 2023
• Study Completion: November 27, 2023
• Last Updated: November 14, 2024
• Results First Posted: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)