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Partial Reinforcement II

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ClinicalTrials.gov Identifier: NCT03774810
Recruitment Status : Recruiting
First Posted : December 13, 2018
Last Update Posted : July 3, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:

The study is a three phase sequential study of the medical treatment of insomnia with zolpidem. All participating subjects will receive one month of standard nightly treatment. If the subject has a positive treatment response they continue in the study and are randomized to one of four conditions: intermittent dosing (3-5 pills week, full dose), or one of three variable dose conditions (nightly pill use where any given pill is a variable dose). Standard treatment will last for 4 weeks. The experimental phase will extend over two periods. The first period will last for 12 weeks. The second period will last for 36 weeks. Both periods include:

• Taking a pill 30 minutes prior to bedtime.

In one case, this will involve taking 3-5 pills per week. In the remaining condition pills will be taken on each and every night. Depending on the specific group that the subject is assigned to, they will either receive 10mg or 5mg of zolpidem (variable by age and sex) or a variable dose of zolpidem on a nightly basis (range from 0 mg to 10 mg per night).

  • Completing a sleep diary each day;
  • Completing 6 to 7 questionnaires each week;
  • A monthly visit to Penn to return your medication foil packs and to receive a new foil pack with the next month of medication.

During Phases 3&4, the subject will be asked to undergo quarter annual physicals so that we can optimally track their health and wellbeing. The physicals will involve standard vitals measures (e.g., temperature, blood pressure, height and weight, etc.) and, based on the judgement of the research clinician, may involve an EKG and blood and urine chemistries.

If the subject does not experience a treatment response or (following a treatment response) experiences a relapse of insomnia, they will not continue in the study but will be given the opportunity to be treated with Cognitive Behavioral Therapy for Insomnia (CBT-I) at no cost. Assessments of the subjects clinical status will be based on your daily sleep diaries and weekly questionnaires.


Condition or disease Intervention/treatment Phase
Insomnia Insomnia Chronic Drug: Zolpidem tartrate Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double Blinded
Primary Purpose: Treatment
Official Title: Three Approaches to Maintenance Therapy for Chronic Insomnia in Older Adults
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Continuous
Nightly active dose (QHS). The intervention is zolpidem tartrate 5 mg or 10 mg.
Drug: Zolpidem tartrate
Zolpidem Tartrate, 5mg for men older than 60 and women of all ages. 10 mg for men younger than 60.
Other Names:
  • zolpidem
  • ambien

Experimental: Partial Reinforcement 1
1 active dose per week with 6 placebos interspersed between the active dose. The intervention is zolpidem tartrate 5 mg or 10 mg.
Drug: Zolpidem tartrate
Zolpidem Tartrate, 5mg for men older than 60 and women of all ages. 10 mg for men younger than 60.
Other Names:
  • zolpidem
  • ambien

Experimental: Partial Reinforcement 3
3 active doses per week with 4 placebos interspersed between the active doses. The intervention is zolpidem tartrate 5 mg or 10 mg.
Drug: Zolpidem tartrate
Zolpidem Tartrate, 5mg for men older than 60 and women of all ages. 10 mg for men younger than 60.
Other Names:
  • zolpidem
  • ambien

Experimental: Low Frequency Intermittent Dosing
1 to 3 active doses per week PRN. The intervention is zolpidem tartrate 5 mg or 10 mg.
Drug: Zolpidem tartrate
Zolpidem Tartrate, 5mg for men older than 60 and women of all ages. 10 mg for men younger than 60.
Other Names:
  • zolpidem
  • ambien




Primary Outcome Measures :
  1. Insomnia Relapse [ Time Frame: 1 year ]
    Tracking Relapse via assessing daily sleep diary responses.


Secondary Outcome Measures :
  1. Sleep Continuity [ Time Frame: 1 year ]
    Assess sleep continuity by assessing daily sleep diary responses.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with chronic insomnia will meet DSM-5 criteria for Insomnia Disorder, ICSD-3, and RDC criteria for Psychophysiologic Insomnia. In addition, all subjects will have a sleep initiation and/or a sleep maintenance complaint (> 30 min. to fall asleep and/or > 30 min. of wakefulness during the night) with a problem frequency > 3 nights/wk and problem duration > 3 mo. This profile must be evident at both intake (based on retrospective reports) and as an average profile from the two weeks of baseline diaries (prospective sampling).

Exclusion Criteria:

  • currently in treatment for insomnia, unstable medical or psychiatric illness, a history of treatment failure with zolpidem, discontinuation of zolpidem owing to side effects, and/or current experience, or history, of parasomnias (within the last 5 years).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774810


Contacts
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Contact: Breanna D'Antonio, BS 2157464378 bdant@upenn.edu

Locations
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United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Breanna D'Antonio, BS         
Principal Investigator: Michael Perlis, PhD         
Sponsors and Collaborators
University of Pennsylvania
National Institutes of Health (NIH)
National Institute on Aging (NIA)

Additional Information:
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03774810     History of Changes
Other Study ID Numbers: 831801
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Plan not yet decided.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by University of Pennsylvania:
insomnia
sleep
chronic insomnia
zolpidem
ambien
Additional relevant MeSH terms:
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Zolpidem
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action