The Role of Partial Reinforcement in the Long Term Management of Insomnia
Condition: Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      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.
    


Intervention name(s): Zolpidem; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): sedative-hypnotic; Placebo
Other intervention name(s): Ambien
Intervention MeSH terms: Zolpidem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Primary Insomnia; Cognitive Behavioral Therapy; Insomnia; Sleep; Zolpidem; Ambien; CBT; CBT-I