- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03687086
Sleep Without Insomnia or The Use of Chronic Hypnotics (SWITCH)
December 8, 2023 updated by: Constance Fung, MD, MSHS, University of California, Los Angeles
A Novel Mechanism for Helping Older Adults Discontinue Use of Sleeping Pills
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
188
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- University of California, Los Angeles
-
Los Angeles, California, United States, 90073
- VA Greater Los Angeles
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Program A
cognitive behavioral therapy type A plus medications in packaging type A
|
Cognitive behavioral therapy type A plus medications prepared in packaging type A.
|
Active Comparator: Program B
cognitive behavioral therapy type B plus medications in packaging type B
|
Cognitive behavioral therapy type B plus medications in packaging type B.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rates of hypnotic discontinuation
Time Frame: 6 months after treatment ends
|
Rates of discontinuation of target medication
|
6 months after treatment ends
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insomnia Severity Index
Time Frame: An average of 9 weeks from randomization and 6 months after treatment ends
|
Insomnia severity based on self-report
|
An average of 9 weeks from randomization and 6 months after treatment ends
|
Dysfunctional Beliefs and Attitudes About Sleep - Medication Scale ratings
Time Frame: An average of 9 weeks from randomization and 6 months after treatment ends
|
Expectancies for hypnotics based on self-report (range 0 to 10; average score of medication items)
|
An average of 9 weeks from randomization and 6 months after treatment ends
|
Rates of hypnotic discontinuation
Time Frame: An average of 9 weeks from randomization
|
Rates of hypnotic discontinuation
|
An average of 9 weeks from randomization
|
Hypnotic dose
Time Frame: An average of 9 weeks from randomization
|
Dose of hypnotic
|
An average of 9 weeks from randomization
|
Hypnotic dose
Time Frame: 6 months after treatment ends
|
Dose of hypnotic
|
6 months after treatment ends
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Digit Symbol Substitution
Time Frame: An average of 9 weeks from randomization and 6 months after treatment ends
|
Objective measure of processing speed
|
An average of 9 weeks from randomization and 6 months after treatment ends
|
Mini-Mental State Examination
Time Frame: An average of 9 weeks from randomization and 6 months after treatment ends
|
Measure of cognition
|
An average of 9 weeks from randomization and 6 months after treatment ends
|
Trails A&B
Time Frame: An average of 9 weeks from randomization and 6 months after treatment ends
|
Objective measure of cognition
|
An average of 9 weeks from randomization and 6 months after treatment ends
|
One-leg Balance test
Time Frame: An average of 9 weeks from randomization and 6 months after treatment ends
|
Objective measure of balance measured in participants in the in-person pathway only
|
An average of 9 weeks from randomization and 6 months after treatment ends
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Constance Fung, MD, MSHS, UCLA, VA Greater Los Angeles
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 11, 2018
Primary Completion (Actual)
November 27, 2023
Study Completion (Actual)
November 27, 2023
Study Registration Dates
First Submitted
September 19, 2018
First Submitted That Met QC Criteria
September 25, 2018
First Posted (Actual)
September 27, 2018
Study Record Updates
Last Update Posted (Estimated)
December 12, 2023
Last Update Submitted That Met QC Criteria
December 8, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-001009
- R01AG057929 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Compliance at one of the sites is not permitting data sharing.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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