Neuromodulation of Trauma Memories in PTSD & Alcohol Dependence

NCT01055171 | Completed Phase 2 Results DMC

• 2 other identifiers: 194891RC1AA019019-01
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Dependence; PTSD

Keywords

alcohol dependence; PTSD; propanolol; craving; beta-block; cue exposure; addiction; memory; trauma; addictive behavior

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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)

Secondary Outcomes (1)

• Proportion of Drinking Days

  90 days prior to participation in study up to 2-week follow up session (Session 3)

Study Arms (2)

Propranolol

ACTIVE COMPARATOR

Patients will receive Propranolol in this condition.

Drug: Propranolol

Placebo

PLACEBO COMPARATOR

Patient to receive placebo in this condition.

Drug: Placebo

Interventions

Propranolol DRUG

40 mg; Single Administration.

Propranolol

Placebo DRUG

40 mg; Single Dose.

Placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

MUSC

Charleston, South Carolina, 294258908, United States

Location

MeSH Terms

Conditions

Alcoholism; Stress Disorders, Post-Traumatic; Behavior, Addictive; Wounds and Injuries

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

Lack of a "no retrieval" control group. Lack of determination of plasma propranolol levels following the medicated retrieval session. The sample size was insufficient to assess the more distal effects at 1-week follow-up.

Results Point of Contact

• Title: Dr. Michael Saladin
• Organization: Medical University of South Carolina

saladinm@musc.edu

843-792-5306

Study Officials

• Michael E Saladin, Ph.D.

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2010
• First Posted: January 25, 2010
• Study Start: January 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: March 8, 2016
• Results First Posted: May 19, 2014

Record last verified: 2012-09

Locations

US (1)