Back to resultsSleep Without Insomnia or The Use of Chronic Hypnotics (SWITCH)
Primary Purpose
Sleep Initiation and Maintenance Disorders
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Program A
Program B
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Initiation and Maintenance Disorders
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
Sites / Locations
- VA Greater Los Angeles
- University of California, Los Angeles
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Program A
Program B
Arm Description
cognitive behavioral therapy type A plus medications in packaging type A
cognitive behavioral therapy type B plus medications in packaging type B
Outcomes
Primary Outcome Measures
Rates of hypnotic discontinuation
Rates of discontinuation of target medication
Secondary Outcome Measures
Insomnia Severity Index
Insomnia severity based on self-report
Dysfunctional Beliefs and Attitudes About Sleep - Medication Scale ratings
Expectancies for hypnotics based on self-report (range 0 to 10; average score of medication items)
Rates of hypnotic discontinuation
Rates of hypnotic discontinuation
Hypnotic dose
Dose of hypnotic
Hypnotic dose
Dose of hypnotic
Full Information
NCT ID
NCT03687086
First Posted
September 19, 2018
Last Updated
February 28, 2023
Sponsor
University of California, Los Angeles
Collaborators
US Department of Veterans Affairs, Virginia Commonwealth University, National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT03687086
Brief Title
Sleep Without Insomnia or The Use of Chronic Hypnotics
Acronym
SWITCH
Official Title
A Novel Mechanism for Helping Older Adults Discontinue Use of Sleeping Pills
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 11, 2018 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
US Department of Veterans Affairs, Virginia Commonwealth University, National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Initiation and Maintenance Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
188 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Program A
Arm Type
Experimental
Arm Description
cognitive behavioral therapy type A plus medications in packaging type A
Arm Title
Program B
Arm Type
Active Comparator
Arm Description
cognitive behavioral therapy type B plus medications in packaging type B
Intervention Type
Other
Intervention Name(s)
Program A
Intervention Description
Cognitive behavioral therapy type A plus medications prepared in packaging type A.
Intervention Type
Other
Intervention Name(s)
Program B
Intervention Description
Cognitive behavioral therapy type B plus medications in packaging type B.
Primary Outcome Measure Information:
Title
Rates of hypnotic discontinuation
Description
Rates of discontinuation of target medication
Time Frame
6 months after treatment ends
Secondary Outcome Measure Information:
Title
Insomnia Severity Index
Description
Insomnia severity based on self-report
Time Frame
An average of 9 weeks from randomization and 6 months after treatment ends
Title
Dysfunctional Beliefs and Attitudes About Sleep - Medication Scale ratings
Description
Expectancies for hypnotics based on self-report (range 0 to 10; average score of medication items)
Time Frame
An average of 9 weeks from randomization and 6 months after treatment ends
Title
Rates of hypnotic discontinuation
Description
Rates of hypnotic discontinuation
Time Frame
An average of 9 weeks from randomization
Title
Hypnotic dose
Description
Dose of hypnotic
Time Frame
An average of 9 weeks from randomization
Title
Hypnotic dose
Description
Dose of hypnotic
Time Frame
6 months after treatment ends
Other Pre-specified Outcome Measures:
Title
Digit Symbol Substitution
Description
Objective measure of processing speed
Time Frame
An average of 9 weeks from randomization and 6 months after treatment ends
Title
Mini-Mental State Examination
Description
Measure of cognition
Time Frame
An average of 9 weeks from randomization and 6 months after treatment ends
Title
Trails A&B
Description
Objective measure of cognition
Time Frame
An average of 9 weeks from randomization and 6 months after treatment ends
Title
One-leg Balance test
Description
Objective measure of balance measured in participants in the in-person pathway only
Time Frame
An average of 9 weeks from randomization and 6 months after treatment ends
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Constance Fung, MD, MSHS
Organizational Affiliation
UCLA, VA Greater Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Greater Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Compliance at one of the sites is not permitting data sharing.
Learn more about this trial
Sleep Without Insomnia or The Use of Chronic Hypnotics
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