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Tapering Strategies for Sleeping Pill Dependence

Phase 2

Waitlist Available

Led By Jack D Edinger, Ph.D.

Research Sponsored by National Jewish Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Currently using one or more BZD or newer BzRA hypnotics at bedtime for insomnia management

Have been using one or more such agents at least 5 nights/week for at least the past 12 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up six-month follow up phase

Awards & highlights

Study Summary

This trial will compare two treatments to help people stop taking sleeping pills, one using hypnosis and one not.

Who is the study for?

This trial is for adults who've been using certain sleep medications nightly for over a year, want to stop but have failed before. They must have mild insomnia without meds and can't join if they have unstable mental health issues, substance abuse (except hypnotics), severe illnesses like cancer or dementia, other untreated sleep disorders, or use meds that disrupt sleep.Check my eligibility

What is being tested?

The study tests two ways of stopping sleep meds while getting Cognitive Behavioral Therapy for Insomnia (CBTI). One group knows when their medication dose is reduced (open-label taper), the other doesn't (blinded taper). The goal is to see which method helps more people successfully quit these meds.See study design

What are the potential side effects?

Potential side effects aren't specified here but generally could include withdrawal symptoms such as anxiety, insomnia rebound, mood changes, and physical discomfort. CBTI itself has no known side effects but changing medication routines should be monitored by professionals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently taking medication for insomnia at bedtime.

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I have been using medication for my condition almost every night for the past year.

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I have mild insomnia symptoms without using sleep medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ six-month follow up phase

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~six-month follow up phase

This trial's timeline: 3 weeks for screening, Varies for treatment, and six-month follow up phase for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hypnotic Discontinuation Rate As Assessed By Analysis of Study Pharmaceutical Records

Secondary outcome measures

Nights of Hypnotic use/week

Use of over the counter sleep aids (e.g. Benadryl) as well as use of substances (alcohol, marijuana)

Weekly average dosage of hypnotic used in diazepam equivalents

Side effects data

From 2020 Phase 4 trial • 133 Patients • NCT03075501

Dry mouth

Shakiness/Trembling

Heart racing

High heart rate and blood pressure

100%

80%

60%

40%

20%

Study treatment Arm

20mg Methamphetamine

0mg Methamphetamine (Placebo)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Blinded Hypnotic Medication Taper (BT)Experimental Treatment1 Intervention

Participants assigned to the Blinded Taper group will not know the medication dose they receive during the Structured Medication Taper (SMT) phase.

Group II: Open-Label Hypnotic Medication Taper (OLT)Active Control1 Intervention

Participants assigned to the Open-Label Hypnotic Medication Taper group will know the medication dose they receive during the SMT phase.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH

2,468 Previous Clinical Trials

2,619,089 Total Patients Enrolled

National Jewish HealthLead Sponsor

140 Previous Clinical Trials

315,976 Total Patients Enrolled

Jack D Edinger, Ph.D.Principal InvestigatorNational Jewish Health

1 Previous Clinical Trials

74 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Blinded Hypnotic Medication Taper (BT) a risk-free option for patients?

"The safety rating of Blinded Hypnotic Medication Taper (BT) is 2 since it has reached Phase 2 in the clinical trial process. Data on its efficacy do not exist yet, however there are indications that it is safe to use."

Answered by AI

Are there any current opportunities for people to participate in this experiment?

"The trial, whose original posting date was December 16th 2019, is not presently recruiting. Nonetheless, 213 other clinical trials are actively inviting patients to join their research at this time according to the information hosted on clinicialtrials.gov."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Use of Blinded Tapering for Hypnotic Discontinuation

2019. "Use of Blinded Tapering for Hypnotic Discontinuation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04050176.

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