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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
  Purpose

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 Intervention Phase
Alcohol Dependence
PTSD
Drug: Propranolol
Drug: Placebo
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • 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.


Enrollment: 44
Study Start Date: January 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01055171

Locations
United States, South Carolina
MUSC
Charleston, South Carolina, United States, 294258908
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Michael E Saladin, Ph.D. Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01055171     History of Changes
Other Study ID Numbers: 19489, 1RC1AA019019-01
Study First Received: January 21, 2010
Results First Received: April 18, 2014
Last Updated: April 18, 2014
Health Authority: United States: Food and Drug Administration

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:
Alcoholism
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Propranolol
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 27, 2014