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Neuromodulation of Trauma Memories in PTSD & Alcohol Dependence

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alcohol Dependence PTSD Drug: Propranolol Drug: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment Implications of Trauma Memory Modulation for PTSD & Alcohol Dependence
Study Start Date : January 2010
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Propranolol
Patients will receive Propranolol in this condition.
 Drug: Propranolol
40 mg; Single Administration.
Placebo Comparator: Placebo
Patient to receive placebo in this condition.
 Drug: Placebo
40 mg; Single Dose.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01055171


Locations
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United States, South Carolina
MUSC
Charleston, South Carolina, United States, 294258908
Sponsors and Collaborators
Medical University of South Carolina
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Michael E Saladin, Ph.D. Medical University of South Carolina
More Information
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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01055171    
Other Study ID Numbers: 19489
1RC1AA019019-01 ( U.S. NIH Grant/Contract )
First Posted: January 25, 2010    Key Record Dates
Results First Posted: May 19, 2014
Last Update Posted: March 8, 2016
Last Verified: September 2012
Keywords provided by Medical University of South Carolina:
alcohol dependence
PTSD
propanolol
craving
beta-block
 cue exposure
addiction
memory
trauma
addictive behavior
Additional relevant MeSH terms:
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Alcoholism
Mental Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Propranolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
 Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents