Neuromodulation of Trauma Memories in PTSD & Alcohol Dependence

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medical University of South Carolina
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Ethanol; Propranolol

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.