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Neuromodulation of Trauma Memories in PTSD & Alcohol Dependence

Primary Purpose

Alcohol Dependence, PTSD

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Propranolol
Placebo
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring alcohol dependence, PTSD, propanolol, craving, beta-block, cue exposure, addiction, memory, trauma, addictive behavior

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • MUSC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Propranolol

Placebo

Arm Description

Patients will receive Propranolol in this condition.

Patient to receive placebo in this condition.

Outcomes

Primary Outcome Measures

Retrieval Session Distress Scores (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)
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)
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)
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

Proportion of Drinking Days
Proportion of drinking days from 90 days prior to the screening to the follow-up period.

Full Information

First Posted
January 21, 2010
Last Updated
February 8, 2016
Sponsor
Medical University of South Carolina
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT01055171
Brief Title
Neuromodulation of Trauma Memories in PTSD & Alcohol Dependence
Official Title
Treatment Implications of Trauma Memory Modulation for PTSD & Alcohol Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence, PTSD
Keywords
alcohol dependence, PTSD, propanolol, craving, beta-block, cue exposure, addiction, memory, trauma, addictive behavior

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propranolol
Arm Type
Active Comparator
Arm Description
Patients will receive Propranolol in this condition.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patient to receive placebo in this condition.
Intervention Type
Drug
Intervention Name(s)
Propranolol
Intervention Description
40 mg; Single Administration.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
40 mg; Single Dose.
Primary Outcome Measure Information:
Title
Retrieval Session Distress Scores (Session 1)
Description
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.
Time Frame
Multiple times throughout cue exposure during retrieval session (Session 1)
Title
Retrieval Session Craving Scores (Session 1)
Description
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.
Time Frame
Multiple times throughout cue exposure during retrieval session (Session 1)
Title
Test Session Distress Scores (Session 2)
Description
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.
Time Frame
Multiple times throughout cue exposure during test session (Session 2)
Title
Test Session Craving Scores (Session 2)
Description
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.
Time Frame
Multiple times throughout cue exposure during test session (Session 2)
Secondary Outcome Measure Information:
Title
Proportion of Drinking Days
Description
Proportion of drinking days from 90 days prior to the screening to the follow-up period.
Time Frame
90 days prior to participation in study up to 2-week follow up session (Session 3)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael E Saladin, Ph.D.
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
MUSC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
294258908
Country
United States

12. IPD Sharing Statement

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Neuromodulation of Trauma Memories in PTSD & Alcohol Dependence

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