Clinical trial NCT03687086: Sleep Without Insomnia or The Use of Chronic Hypnotics
Official title: A Novel Mechanism for Helping Older Adults Discontinue Use of Sleeping Pills
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Initiation and Maintenance Disorders
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: US Department of Veterans Affairs
name: Virginia Commonwealth University
name: National Institute on Aging (NIA)
First posted: 2018-09-27
Enrollment: 188
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Rates of Hypnotic Discontinuation
timeFrame: 6 months after treatment ends (which is an average of 8 months from randomization)
Secondary outcomes:
measure: Insomnia Severity Index
timeFrame: One week post intervention (which is an average of 9 weeks from randomization)
measure: Insomnia Severity Index
timeFrame: 6 months after treatment ends (which is an average of 8 months from randomization)
measure: Dysfunctional Beliefs and Attitudes About Sleep - Medication Subscale
timeFrame: One week post intervention (which is an average of 9 weeks from randomization)
measure: Dysfunctional Beliefs and Attitudes About Sleep - Medication Subscale
timeFrame: 6 months after treatment ends (which is an average of 8 months from randomization)
measure: Rates of Hypnotic Discontinuation
timeFrame: One week post intervention (which is an average of 9 weeks from randomization)
measure: Hypnotic Dose
timeFrame: One week post intervention (which is an average of 9 weeks from randomization)
measure: Hypnotic Dose
timeFrame: 6 months after treatment ends (which is an average of 8 months from randomization)
Other outcomes:
measure: Digit Symbol Substitution
timeFrame: One week post intervention (which is an average of 9 weeks from randomization)
measure: Digit Symbol Substitution
timeFrame: 6 months after treatment ends (which is an average of 8 months from randomization)
measure: Mini-Mental State Examination
timeFrame: One week post intervention (which is an average of 9 weeks from randomization)
measure: Mini-Mental State Examination
timeFrame: 6 months after treatment ends (which is an average of 8 months from randomization)
measure: Trail Making Test A and B
timeFrame: One week post intervention (which is an average of 9 weeks from randomization)
measure: Trail Making Test A and B
timeFrame: 6 months after treatment ends (which is an average of 8 months from randomization)
measure: One-leg Balance Test
timeFrame: One week post intervention (which is an average of 9 weeks from randomization)
measure: One-leg Balance Test
timeFrame: 6 months after treatment ends (which is an average of 8 months from randomization)
Locations:
city: Los Angeles
country: United States
facility: VA Greater Los Angeles
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
affiliation: UCLA, VA Greater Los Angeles
name: Constance Fung, MD, MSHS
role: PRINCIPAL_INVESTIGATOR
References: