Neuromodulation of Trauma Memories in PTSD & Alcohol Dependence
Condition: Alcohol Dependence; PTSD
MeSH terms: Alcoholism
Intervention: Propranolol; Placebo
Intervention description: 40 mg; Single Administration.; 40 mg; Single Dose.
Intervention MeSH terms: Propranolol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: alcohol dependence; PTSD; propanolol; craving; beta-block; cue exposure; addiction; memory; trauma; addictive behavior

Summary:

      The purpose of this study is to examine the effect of propranolol versus placebo on craving,
      distress and cue reactivity to trauma and alcohol cues.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must meet DSM-IV criteria for current alcohol dependence

          -  Participants must have experienced criminal victimization

          -  Use of birth control by female participants

          -  Live within a 50-mile radius of research site

          -  Consent to remain abstinent of all drugs and alcohol for 24 hours prior to patient
             admission and follow-up

          -  Consent to random assignment to propanol or placebo

          -  Individuals must be able to provide informed consent and function at an intellectual
             level sufficient to allow accurate completion of all assessment instruments.

        Exclusion Criteria:

          -  Women who are pregnant, nursing or are of childbearing potential and not using birth
             control.

          -  Evidence or history of significant hematological, endocrine, cardiovascular,
             pulmonary, renal, gastrointestinal or neurological disease

          -  Significant liver impairment

          -  Currently taking anti-arrhythmic agents, psychostimulants or other agents known to
             interfere with heart rate and skin conductance monitoring.

          -  Known or suspected hypersensitivity to propanol

          -  Individuals taking medication that could adversely interact with the study medication,
             including the following: albuterol, insulin or significant inhibitors of CYP2D6

          -  Individuals with bronchial asthma or chronic obstructive pulmonary disease

          -  Prospective participants will be excluded if they are currently receiving
             exposure-based therapy for PTSD.

          -  Individuals with a history of or current psychotic disorder.

          -  Individuals with Addison's disease, Cushing's disease or other diseases of the adrenal
             cortex likely to affect cortisol levels.

          -  Individuals receiving synthetic glucocorticoid therapy, any exogenous therapy, or
             treatment with other agents that interfere with HPA axis function within one month of
             the time of testing.

          -  Individuals with resting heart rates less than 55 bpm.