Neuromodulation of Trauma Memories in PTSD & Alcohol Dependence

PTSD Clinical Trial

Official title:

Treatment Implications of Trauma Memory Modulation for PTSD & Alcohol Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01055171
• Other study ID #: 19489
• Secondary ID: 1RC1AA019019-01
• Status: Completed
• Phase: Phase 2
• First received: January 21, 2010
• Last updated: February 8, 2016
• Start date: January 2010
• Est. completion date: August 2012

Study information

• Verified date: September 2012
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism
• PTSD

Intervention

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

Locations

Country	Name	City	State
United States	MUSC	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Multiple times throughout cue exposure during retrieval session (Session 1)	No
Primary	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.	Multiple times throughout cue exposure during retrieval session (Session 1)	No
Primary	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.	Multiple times throughout cue exposure during test session (Session 2)	No
Primary	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.	Multiple times throughout cue exposure during test session (Session 2)	No
Secondary	Proportion of Drinking Days	Proportion of drinking days from 90 days prior to the screening to the follow-up period.	90 days prior to participation in study up to 2-week follow up session (Session 3)	No