Neuromodulation of Trauma Memories in PTSD & Alcohol Dependence
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Treatment Implications of Trauma Memory Modulation for PTSD & Alcohol Dependence|
- Mean of the Difference of Session 1 and Session 2 Distress Scores (Session 2-Session 1). [ Time Frame: Participants will rate their level of distress at regular intervals throughout both days of cue exposure. ] [ Designated as safety issue: No ]Found by using our Single Item Distress (SID) scale. A study team member asks the participant to verbally report the level of distress they were experiencing using values between 0 and 100, with 0 representing no distress and 100 extreme distress. The difference score was found by subtracting session 1 mean SIDs during cue exposure from session 2 mean SIDs during cue exposure. Therefore the mean of the difference could have ranged anywhere from -100 to 100. Negative mean difference scores reflect a decrease in distress from session 1 (test) to session 2 (retrieval). The lower the mean difference score, the greater the decrease in distress.
- Mean of the Difference of Session 1 and Session 2 Alcohol Craving Scores (Session 2-Session 1). [ Time Frame: Participants will rate their level of craving at regular intervals throughout both days of cue exposure ] [ Designated as safety issue: No ]Found by using our Single Item Craving (SIC) scale. A study team member asks the participant to verbally report the level of craving they were experiencing using values between 0 and 100, with 0 representing no craving and 100 extreme craving. The difference score was found by subtracting session 1 mean SICs during cue exposure from session 2 mean SICs during cue exposure. Therefore the mean of the difference could have ranged anywhere from -100 to 100. Negative mean difference scores reflect a decrease in craving for alcohol from session 1 (test) to session 2 (retrieval). The lower the mean difference score, the greater the decrease in craving.
|Study Start Date:||January 2010|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Propranolol
Patients will receive Propranolol in this condition.
40 mg; Single Administration.
Placebo Comparator: Placebo
Patient to receive placebo in this condition.
40 mg; Single Dose.
Summary and Synthesis: Epidemiological studies have established the occurrence of high rates of AD in persons with PTSD. Likewise, studies of alcohol/drug abuse treatment seekers have documented high rates of trauma exposure and PTSD. The high prevalence of PTSD/AD comorbidity is the cause of enormous human suffering, most of which either goes untreated or is resistant to treatment efforts. Both theory and research concerning the interface between these two disorders suggests that PTSD is associated with the initiation of excessive alcohol use and/or the development of AD by way of an escape/avoidance behavioral mechanism wherein escalating alcohol use is reinforced by its ability to dampen the negative emotions and arousal associated with PTSD. If PTSD is often a primary cause of the initiation and maintenance of AD, then clinical interventions that primarily impact PTSD should lead to significant improvements in craving for, and use of, alcohol. The findings of two recent treatment studies offer especially compelling support for this expectation. Drawing on both basic neuroscience research and a developing body of suggestive clinical/applied research, we were led to consider if the putative memory modulating properties of the adrenergic antagonist propranolol might have therapeutic benefits for PTSD/AD comorbid individuals. Thus, the proposed study will test the hypothesis that the strategic administration of propranolol coupled with the elicitation/retrieval of trauma-related memories will dampen emotional distress, alcohol craving and cue reactivity during subsequent exposure to trauma- and alcohol-related cues. A two-week follow-up laboratory session and clinical assessment will permit us to evaluate whether treatment benefits are maintained over time and if there are any changes in alcohol use and PTSD symptomatology.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01055171
|United States, South Carolina|
|Charleston, South Carolina, United States, 294258908|
|Principal Investigator:||Michael E Saladin, Ph.D.||Medical University of South Carolina|