Sleep Without Insomnia or The Use of Chronic Hypnotics

NCT03687086 | Completed Results

• 2 other identifiers: 18-001009R01AG057929
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 2

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.

Conditions

Sleep Initiation and Maintenance Disorders

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (7)

• Insomnia Severity Index

  One week post intervention (which is an average of 9 weeks from randomization)

• Insomnia Severity Index

  6 months after treatment ends (which is an average of 8 months from randomization)

• Dysfunctional Beliefs and Attitudes About Sleep - Medication Subscale

  One week post intervention (which is an average of 9 weeks from randomization)

• Dysfunctional Beliefs and Attitudes About Sleep - Medication Subscale

  6 months after treatment ends (which is an average of 8 months from randomization)

• Rates of Hypnotic Discontinuation

  One week post intervention (which is an average of 9 weeks from randomization)

Other Outcomes (8)

• Digit Symbol Substitution

  One week post intervention (which is an average of 9 weeks from randomization)

• Digit Symbol Substitution

  6 months after treatment ends (which is an average of 8 months from randomization)

• Mini-Mental State Examination

  One week post intervention (which is an average of 9 weeks from randomization)

Study Arms (2)

Program A

EXPERIMENTAL

cognitive behavioral therapy type A plus medications in packaging type A

Other: Program A

Program B

ACTIVE COMPARATOR

cognitive behavioral therapy type B plus medications in packaging type B

Other: Program B

Interventions

Program A OTHER

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

Program A

Program B OTHER

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

Program 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,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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, Los Angeles: lead
• US Department of Veterans Affairs: collaborator
• Virginia Commonwealth University: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (2)

VA Greater Los Angeles

Los Angeles, California, 90073, United States

Location

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Related Publications (2)

• 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 DERIVED

• 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 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Medicare Part A

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Medicare; Medical Assistance; Public Assistance; Financing, Government; Financing, Organized; Economics; Health Care Economics and Organizations; Insurance, Health; Insurance; Legislation as Topic; Social Control, Formal

Limitations and Caveats

The trial was interrupted by the COVID-19 pandemic. Protocol changes were made in response to the COVID-19 pandemic (see protocol).

Results Point of Contact

• Title: Dr. Constance Fung
• Organization: University of California, Los Angeles and VA Greater Los Angeles Healthcare System

Constance.Fung@va.gov

818 891-7711

Study Officials

• Constance Fung, MD, MSHS

  UCLA, VA Greater Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 19, 2018
• First Posted: September 27, 2018
• Study Start: December 11, 2018
• Primary Completion: November 27, 2023
• Study Completion: November 27, 2023
• Last Updated: December 30, 2024
• Results First Posted: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)