Phase 2
N=57
Neuromodulation of Trauma Memories in PTSD & Alcohol Dependence
Alcohol Dependence · PTSD
Bottom Line
View on ClinicalTrials.gov: NCT01055171 ↗Enrolled (actual)
57
Serious AEs
0.0%
Results posted
May 2014
Primary outcome: Primary: Retrieval Session Distress Scores (Session 1) — 54.5; 73.9 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Propranolol (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Retrieval Session Distress Scores (Session 1) |
54.5; 73.9 | — |
| PRIMARY Retrieval Session Craving Scores (Session 1) |
49.1; 71.6 | — |
| PRIMARY Test Session Distress Scores (Session 2) |
35.1; 48.0 | — |
| PRIMARY Test Session Craving Scores (Session 2) |
51.0; 53.9 | — |
| SECONDARY Proportion of Drinking Days |
42.2; 45.9 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01055171). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.