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Neuromodulation of Trauma Memories in PTSD & Alcohol Dependence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01055171
Recruitment Status : Completed
First Posted : January 25, 2010
Results First Posted : May 19, 2014
Last Update Posted : March 8, 2016
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Medical University of South Carolina

Tracking Information
First Submitted Date  ICMJE January 21, 2010
First Posted Date  ICMJE January 25, 2010
Results First Submitted Date  ICMJE April 18, 2014
Results First Posted Date  ICMJE May 19, 2014
Last Update Posted Date March 8, 2016
Study Start Date  ICMJE January 2010
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2016)
  • Retrieval Session Distress Scores (Session 1) [ Time Frame: Multiple times throughout cue exposure during retrieval session (Session 1) ]
    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.
  • Retrieval Session Craving Scores (Session 1) [ Time Frame: Multiple times throughout cue exposure during retrieval session (Session 1) ]
    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 for alcohol.
  • Test Session Distress Scores (Session 2) [ Time Frame: Multiple times throughout cue exposure during test session (Session 2) ]
    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.
  • Test Session Craving Scores (Session 2) [ Time Frame: Multiple times throughout cue exposure during test session (Session 2) ]
    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 for alcohol.
Original Primary Outcome Measures  ICMJE
 (submitted: January 22, 2010)
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) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2016)
Proportion of Drinking Days [ Time Frame: 90 days prior to participation in study up to 2-week follow up session (Session 3) ]
Proportion of drinking days from 90 days prior to the screening to the follow-up period.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2010)
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) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neuromodulation of Trauma Memories in PTSD & Alcohol Dependence
Official Title  ICMJE Treatment Implications of Trauma Memory Modulation for PTSD & Alcohol Dependence
Brief 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Alcohol Dependence
  • PTSD
Intervention  ICMJE
  • Drug: Propranolol
    40 mg; Single Administration.
  • Drug: Placebo
    40 mg; Single Dose.
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 10, 2012)
44
Original Estimated Enrollment  ICMJE
 (submitted: January 22, 2010)
50
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01055171
Other Study ID Numbers  ICMJE 19489
1RC1AA019019-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Medical University of South Carolina
Original Responsible Party Michael Saladin, Ph.D., Medical University of South Carolina
Current Study Sponsor  ICMJE Medical University of South Carolina
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators  ICMJE
Principal Investigator: Michael E Saladin, Ph.D. Medical University of South Carolina
PRS Account Medical University of South Carolina
Verification Date September 2012

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