Neuromodulation of Trauma Memories in PTSD & Alcohol Dependence

• 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: Medical University of South Carolina
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Information provided by (Responsible Party): Medical University of South Carolina

Tracking Information

• First Submitted Date: January 21, 2010
• First Posted Date: January 25, 2010
• Results First Submitted Date: April 18, 2014
• Results First Posted Date: May 19, 2014
• Last Update Posted Date: March 8, 2016
• Study Start Date: January 2010
• Actual Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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) ]

Current Secondary Outcome Measures (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 (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: Neuromodulation of Trauma Memories in PTSD & Alcohol Dependence
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Alcohol Dependence
• PTSD

Intervention

• Drug: Propranolol
  40 mg; Single Administration.
• Drug: Placebo
  40 mg; Single Dose.

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 10, 2012): 44
• Original Estimated Enrollment (submitted: January 22, 2010): 50
• Actual Study Completion Date: August 2012
• Actual Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 100 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01055171
• Other Study ID Numbers: 19489; 1RC1AA019019-01 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: 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: Medical University of South Carolina
• Original Study Sponsor: Same as current
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

• Principal Investigator: Michael E Saladin, Ph.D.; Medical University of South Carolina

• PRS Account: Medical University of South Carolina
• Verification Date: September 2012