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CBTI plus taper method A for Insomnia (SWITCH Trial)
N/A
Waitlist Available
Led By Constance H Fung, MD MS
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-months after end of treatment
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new method to help older Veterans stop using sleeping pills. The new method combines a gradual reduction in pill dosage with therapy to improve sleep habits. The goal is to see if this approach is better than the usual method in reducing pill use and improving sleep.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-months after end of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-months after end of treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Hypnotic discontinuation
Insomnia Severity Index score
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: CBTI plus Taper method AExperimental Treatment1 Intervention
Participants in this arm will receive CBTI plus the novel hypnotic tapering method.
Group II: CBTI plus Taper method BActive Control1 Intervention
Participants in this arm will receive CBTI plus the usual tapering method used by the VA.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CBTI plus taper method A
2018
N/A
~140
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,681 Total Patients Enrolled
25 Trials studying Insomnia
4,084 Patients Enrolled for Insomnia
Constance H Fung, MD MSPrincipal InvestigatorVA Greater Los Angeles Healthcare System, West Los Angeles, CA
Constance H Fung, MD MSHSPrincipal InvestigatorVA Greater Los Angeles Healthcare System, West Los Angeles, CA
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have bipolar disorder.You are currently taking a medication for a sleep disorder that is not related to the study.You are not willing to stop using sleep medication.You cannot stop taking your sleep medication.You have a high risk of experiencing complications during the outpatient program to stop taking sleep medications.You have a history of seizures.You are taking multiple drugs, including high doses of opioids, for a long time.You do not have a stable place to live.You currently have trouble sleeping or have had trouble sleeping in the past.You have been taking certain medications (like lorazepam, alprazolam, temazepam, clonazepam, and/or zolpidem) for at least 3 months, at least 2 nights per week, to help you sleep.You have not received any treatment for your breathing problems during sleep.You are not a suitable candidate for cognitive-behavioral therapy for insomnia.Your sleep problems may be caused by another sleep disorder like restless legs syndrome, narcolepsy, not getting enough sleep, or problems with your body's natural sleep cycle.
Research Study Groups:
This trial has the following groups:- Group 1: CBTI plus Taper method A
- Group 2: CBTI plus Taper method B
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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