The Role of Partial Reinforcement in the Long Term Management of Insomnia (ADER)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University of Pennsylvania.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00662155
First received: April 16, 2008
Last updated: February 18, 2011
Last verified: February 2011
  Purpose

The lack of scientific attention devoted to the placebo effect as a phenomenon in its own right probably reflects the paucity of theoretical positions within which to organize the existing data and design new research. The proposed investigation 1) is an attempt to advance from a descriptive to an experimental analysis of the placebo effect, taking into account classical conditioning effects, and 2) examines the clinical implications of partial reinforcement as it is applied to the treatment of insomnia. Subjects with primary insomnia will be treated with zolpidem for a period of one month and then randomized to one of four groups for a period of 12 weeks: one receiving full dose zolpidem on a nightly basis (continuous reinforcement), one receiving full dose zolpidem on 14 of 28 nights where placebo is provided on non-drug nights (partial reinforcement), one receiving full dose zolpidem on 14 of 28 nights where no pills are imbibed on non-drug nights (intermittent dosing), and one receiving 5 mg dose zolpidem on a nightly basis (continuous reinforcement with half the standard dose). Following treatment, subjects will be entered into an extinction protocol during which they will 1) continue on the schedule assigned during the experimental period, 2) receive only placebo, or 3) receive neither drug nor placebo. Sleep and daily functioning will be monitored on a daily basis via sleep diaries for the duration of the study. It is hypothesized that, holding cumulative dose constant, a partial schedule of reinforcement will enable patients to better maintain their clinical gains as compared to subjects that receive either continuous reinforcement with half the standard dose or half the frequency of use.

Relevance: The proposed research is not an attempt to offer a behavioral alternative to drug treatment; it is an attempt to acknowledge and capitalize on a behavioral dimension in the design of drug treatment protocols. The value of the proposed research resides in its capacity to provide for the long term treatment of insomnia in a manner that increases the durability of pharmacotherapy while reducing the overall amount of medication required. If proven effective in the current application, this new approach to pharmacotherapy and placebo effects is likely to stimulate new interdisciplinary research for the treatment of a variety of chronic diseases.


Condition Intervention
Primary Insomnia
Drug: Zolpidem

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Role of Partial Reinforcement in the Long Term Management of Insomnia

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • sleep diary [ Time Frame: daily ] [ Designated as safety issue: No ]
    The standard measure for clinical trials research in insomnia is the sleep diary. This prospective self report measurement tool provides an assessment of sleep continuity as a function of treatment.


Secondary Outcome Measures:
  • Sleep Diary [ Time Frame: daily ] [ Designated as safety issue: No ]
    The same sleep diary variables will be used, but for assessment of relapse of insomnia during the "Experimental" and "Extinction" phases.


Estimated Enrollment: 180
Study Start Date: July 2006
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Continuous 1
combination of medication and placebo
Drug: Zolpidem
sedative-hypnotic
Other Name: Ambien
Experimental: Partial
combination of medication and placebo
Drug: Zolpidem
sedative-hypnotic
Other Name: Ambien
Experimental: Intermittent
combination of medication and placebo
Drug: Zolpidem
sedative-hypnotic
Other Name: Ambien
Experimental: Continuous 2
combination of medication and placebo
Drug: Zolpidem
sedative-hypnotic
Other Name: Ambien

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with insomnia will meet RDC criteria for psychophysiologic insomnia(99). These criteria are provided in Appendix 2. In addition, the complaint of disturbed sleep will have one or more of the following characteristics:

    • > 30 minutes to fall asleep (Initial Insomnia)
    • 2 awakenings per night of >15 minutes duration and/or wake after sleep onset time of > 30 minutes (Middle Insomnia)
    • An awakening of > 30 minutes prior to the desired "wake up" time (Late Insomnia)
    • Any two of the above complaints (Mixed Insomnia)

Additionally, total sleep time will not exceed 6 hours (unless the sleep efficiency quotient is < 80%) and the problem frequency must be equal to or greater than 4 nights/ week (severe insomnia) with a problem duration > 6 months (chronic insomnia). This profile must be evident at both intake (based on retrospective reports) and as an average profile from the two weeks of baseline diaries (based on prospective sampling).

Exclusion Criteria:

  • Unstable medical or psychiatric illness Assessed with the Mini International Neuropsychiatric Interview (MINI) and the The Schedule for Affective Disorders and Schizophrenia-Lifetime Version (SADS-L) To assure that the insomnia is not secondary to these factors
  • Symptoms suggestive of sleep disorders other than insomnia Assessed with the SDS-CL To assure that the insomnia is not secondary to these factors
  • Polysomnographic data indicating sleep disorders other than insomnia Assessed with PSG in collaboration with our sleep medicine consultants To assure that the insomnia is not secondary to these factors
  • History of head injury with a sustained loss of consciousness Assessed by self report during the Intake Interview To help assure that the EEG measures are unconfounded by brain damage
  • Evidence of active illicit substance use or fitting criteria for alcohol abuse or dependence Assessed with a structured psychiatric interview schedule (the MINI) , written versions of clinical interview queries regarding alcohol use, abuse and dependence (the AUDIT and CAGE), the toxicology screen which is part of the clinical chemistries obtained during the screening physical. To assure that the insomnia is not secondary to these factors and to assure that substance use/abuse does not confound treatment.
  • Use of CNS active medications, antidepressants, and hypnotics other than zolpidem Assessed by self report and from the toxicology screen which is part of the clinical chemistries obtained during the screening physical. To help assure that the clinical effects observed in this study are due to the study medication and schedule of reinforcement.
  • Inadequate language comprehension Informally, assessed by the Clinical Research Coordinator during Intake Interview To assure the quality of self report data as all the measures are in English.
  • Pregnancy Assessed by self report and from the clinical chemistries data obtained during the screening physical. Excluded so as to 1) prevent the fetus from exposure to the study medication (although it should be noted that the medication is considered FDA pregnancy category B) and 2) control for the biopsychosocial changes that occur with pregnancy and may alter the response to the study medication and schedule of reinforcement.
  • No first-degree relatives with bipolar disorder or schizophrenia Assessed by self report and a structured psychiatric interview schedule (the SADs). Excluded to reduce risk for first onset during the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00662155

Contacts
Contact: Erin Bremer, B.S.N. 215-573-5935 ebremer@mail.med.upenn.edu

Locations
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Erin Bremer, B.S.N.    215-573-5935    ebremer@mail.med.upenn.edu   
Principal Investigator: Michael Perlis, Ph.D.         
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Michael Perlis, Ph.D. University of Pennsylvania
  More Information

Additional Information:
No publications provided

Responsible Party: Michael Perlis, Ph.D. / Primay Investigator, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00662155     History of Changes
Other Study ID Numbers: RSRB # 14533, 1R01AT003332-01A1
Study First Received: April 16, 2008
Last Updated: February 18, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Primary Insomnia
Cognitive Behavioral Therapy
Insomnia
Sleep
Zolpidem
Ambien
CBT
CBT-I

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
Zolpidem
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 23, 2014