Sleep Without Insomnia or The Use of Chronic Hypnotics

NCT ID: NCT03687086

Last Updated: 2024-12-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 188 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-11
• Study Completion Date: 2023-11-27

Brief Summary

Sleeping medications, called hypnotics, are often prescribed for insomnia and are associated with adverse health outcomes in older adults. Response rates to hypnotic discontinuation programs are often inadequate, and many patients eventually resume use of hypnotics, suggesting that other mechanisms need to be targeted to achieve and sustain high rates of non-use. Current programs focus on the tapering of hypnotics and/or the treatment of insomnia symptoms. These programs employ strategies such as supervised gradual taper, cognitive behavioral therapy targeting hypnotic withdrawal, and/or cognitive behavioral therapy for insomnia. Evidence suggests that another mechanism involving "placebo" effects may be a viable target for achieving and sustaining higher discontinuation rates. Cognitive expectancies play a key role in producing placebo effects, which are characterized as real improvements in sleep arising from psychosocial aspects of treatment rather than drug effects alone. In this study, investigators are comparing two programs for discontinuing hypnotic medications-a program that addresses placebo effects associated with hypnotic use and a program that does not address these effects.

Detailed Description

Investigators will complete a 5-year randomized trial, recruiting participants from two healthcare systems using a three-step screening process that minimizes time and travel burden to participants. Step 1 (identification of participants): Investigators will identify participants aged >= 55 years who have current prescriptions for lorazepam, temazepam, alprazolam, and/or zolpidem for >= 3 months. Investigators will use three sources to identify these patients: medication lists from electronic health records/administrative data, consults to insomnia clinic, and referrals from providers. The research team will mail a recruitment letter (with opt-out card) to patients identified from these sources. Step 2 (phone screening for current or prior insomnia and current hypnotic use); Patients who endorse a history of insomnia symptoms and current hypnotic use will be invited for an in-person screening. Step 3 (in-person screening for remaining eligibility criteria (and baseline assessments): After written consent, the in-person screening visit consists of a comprehensive sleep, mental health, and brief physical health assessment. Individuals who meet study criteria and agree to continue will be randomized to receive either the Program A (N=94) or Program B (N=94). The interventions are approximately 2 months. Following intention-to-treat principles, all randomized participants will complete an assessment immediately after the intervention ends and 6 months after completing treatment. Participants will be compensated monetarily for assessment visits. Investigators will measure hypnotic expectancies, hypnotic discontinuation, and insomnia severity post-treatment and at 6-months follow-up.

Conditions

Sleep Initiation and Maintenance Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Program A

cognitive behavioral therapy type A plus medications in packaging type A

Group Type: EXPERIMENTAL

Program A

Intervention Type: OTHER

Cognitive behavioral therapy type A plus medications prepared in packaging type A.

Program B

cognitive behavioral therapy type B plus medications in packaging type B

Group Type: ACTIVE_COMPARATOR

Program B

Intervention Type: OTHER

Cognitive behavioral therapy type B plus medications in packaging type B.

Interventions

Program A

Cognitive behavioral therapy type A plus medications prepared in packaging type A.

Intervention Type: OTHER

Program B

Cognitive behavioral therapy type B plus medications in packaging type B.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age >= 55 years
• Use of lorazepam, alprazolam, temazepam,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 sessions over 9 weeks

Exclusion Criteria

High risk for complications in outpatient hypnotic discontinuation program:

• Seizure disorder
• Supratherapeutic or high baseline hypnotic dose (> diazepam-equivalent of 8 mg/night).
• High baseline risk of complicated withdrawal;benzodiazepine intoxication or current or past symptoms of complicated benzodiazepine/alcohol withdrawal (e.g.,seizure, delirium at baseline (prior to taper))
• 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 multiple pharmacies during overlapping time periods, diversion)

Discontinuation of hypnotic not appropriate:

•Study-targeted hypnotic used to treat another clinical condition (e.g., panic disorder)

Poor candidate for cognitive behavioral therapy for insomnia:

• 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 (respiratory event index >= 15 and < 30 plus excessive daytime sleepiness, or REI >=30)
• Medically/psychiatrically unstable (e.g., planned major surgery during the study period;psychosis, suicidal, active alcohol/substance abuse based on history and medical records)
• Unstable housing situation

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Constance Fung, MD, MSHS

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Constance Fung, MD, MSHS

Role: PRINCIPAL_INVESTIGATOR

UCLA, VA Greater Los Angeles

Locations

VA Greater Los Angeles

Los Angeles, California, United States

University of California, Los Angeles

Los Angeles, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39374004 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37526436 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01AG057929

Identifier Type: NIH

Identifier Source: secondary_id

View Link

18-001009

Identifier Type: -

Identifier Source: org_study_id