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Completed

NCT Number: NCT03687086

Sleep Without Insomnia or The Use of Chronic Hypnotics

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Los Angeles, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Program A

Other

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

Program B

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Insomnia Severity Index

    Time frame: One week post intervention (which is an average of 9 weeks 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.

  2. Insomnia Severity Index

    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.

  3. Dysfunctional Beliefs and Attitudes About Sleep - Medication Subscale

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

    These 3-items were used to measure hypnotic expectancies. Items ranged from 0 (strongly disagree/least expectancy) to 10 (strongly agree/most expectancy). The scale score is the average of the 3 items and ranged from 0-10 with higher scores indicating greater hypnotic expectancy. Higher hypnotic expectancies are worse outcomes, lower hypnotic expectancies are better outcomes.

  4. Dysfunctional Beliefs and Attitudes About Sleep - Medication Subscale

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

    These 3-items were used to measure hypnotic expectancies. Items ranged from 0 (strongly disagree/least expectancy) to 10 (strongly agree/most expectancy).The scale score is the average of the 3 items and ranged from 0-10 with higher scores indicating greater hypnotic expectancy. Higher hypnotic expectancies are worse outcomes, lower hypnotic expectancies are better outcomes.

  5. Rates of Hypnotic Discontinuation

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

    The percentage of participants who had stopped taking a benzodiazepine or z-drug one week after the end of treatment . This outcome was measured with 7-day self-reported medication logs.

  6. Hypnotic Dose

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

    The mean daily dose based on self-reported 7-day medication log (in diazepam-equivalent milligrams).

  7. Hypnotic Dose

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

    The mean daily dose based on self-reported 7-day medication log (in diazepam-equivalent milligrams).

Other outcomes

  1. Digit Symbol Substitution

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

    This test measures processing speed, working memory, visuospatial processing, and attention. It is sensitive to cognitive impairment and change in cognition. The score is based on the number of symbols that the person correctly substitutes in 90 seconds. Total score can range from 0 to 135, with higher scores indicating better cognitive performance.

  2. Digit Symbol Substitution

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

    This test measures processing speed, working memory, visuospatial processing, and attention. It is sensitive to cognitive impairment and change in cognition. The score is based on the number of symbols that the person correctly substitutes in 90 seconds. Total score can range from 0 to 135, with higher scores indicating better cognitive performance.

  3. Mini-Mental State Examination

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

    This is a 30-item test of cognitive function. Scores range from 0-30, with higher scores indicating better cognitive function.

  4. Mini-Mental State Examination

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

    This is a 30-item test of cognitive function. Scores range from 0-30, with higher scores indicating better cognitive function.

  5. Trail Making Test A and B

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

    Objective measure of cognitive executive functioning. The scores is the number of seconds it takes to complete the test. Lower scores indicate better cognitive functioning.

  6. Trail Making Test A and B

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

    Objective measure of cognitive executive functioning. The scores is the number of seconds it takes to complete the test. Lower scores indicate better cognitive functioning.

  7. One-leg Balance Test

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

    Objective measure of balance. Participants are timed while they stand on one-leg for up to 60 seconds. Score is the number of seconds able to stand on one-leg. Higher scores indicate better balance.

  8. One-leg Balance Test

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

    Objective measure of balance. Participants are timed while they stand on one-leg for up to 60 seconds. Score is the number of seconds able to stand on one-leg. Higher scores indicate better balance.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Institute on Aging (NIA)
  • US Department of Veterans Affairs
  • Virginia Commonwealth University

Registry information

Official study title

A Novel Mechanism for Helping Older Adults Discontinue Use of Sleeping Pills

Acronym: SWITCH

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Sep 27, 2018
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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