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Neuromodulation of Trauma Memories in PTSD & Alcohol Dependence

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01055171
First received: January 21, 2010
Last updated: April 18, 2014
Last verified: September 2012

January 21, 2010
April 18, 2014
January 2010
August 2012   (final data collection date for primary outcome measure)
  • 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.
Alcohol craving and physiological arousal ( heart rate, skin conductance and blood pressure) during cue exposure session. [ Time Frame: During initial cue exposure ( same day as drug administration) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01055171 on ClinicalTrials.gov Archive Site
Not Provided
Alcohol craving and physiological arousal ( heart rate, skin conductance and blood pressure) during cue exposure session. [ Time Frame: Fourteen day follow-up assesment ( one week after drug admin) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Neuromodulation of Trauma Memories in PTSD & Alcohol Dependence
Treatment Implications of Trauma Memory Modulation for 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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Alcohol Dependence
  • PTSD
  • Drug: Propranolol
    40 mg; Single Administration.
  • Drug: Placebo
    40 mg; Single Dose.
  • Active Comparator: Propranolol
    Patients will receive Propranolol in this condition.
    Intervention: Drug: Propranolol
  • Placebo Comparator: Placebo
    Patient to receive placebo in this condition.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
August 2012
August 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01055171
19489, 1RC1AA019019-01
Yes
Medical University of South Carolina
Medical University of South Carolina
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Michael E Saladin, Ph.D. Medical University of South Carolina
Medical University of South Carolina
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP