Neuromodulation of Trauma Memories in PTSD & Alcohol Dependence
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ClinicalTrials.gov Identifier: NCT01055171 |
Recruitment Status :
Completed
First Posted : January 25, 2010
Results First Posted : May 19, 2014
Last Update Posted : March 8, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alcohol Dependence PTSD | Drug: Propranolol Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 44 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Treatment Implications of Trauma Memory Modulation for PTSD & Alcohol Dependence |
Study Start Date : | January 2010 |
Actual Primary Completion Date : | August 2012 |
Actual Study Completion Date : | August 2012 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Propranolol
Patients will receive Propranolol in this condition.
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Drug: Propranolol
40 mg; Single Administration. |
Placebo Comparator: Placebo
Patient to receive placebo in this condition.
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Drug: Placebo
40 mg; Single Dose. |
- 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.
- 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.

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Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01055171
United States, South Carolina | |
MUSC | |
Charleston, South Carolina, United States, 294258908 |
Principal Investigator: | Michael E Saladin, Ph.D. | Medical University of South Carolina |
Responsible Party: | Medical University of South Carolina |
ClinicalTrials.gov Identifier: | NCT01055171 |
Other Study ID Numbers: |
19489 1RC1AA019019-01 ( U.S. NIH Grant/Contract ) |
First Posted: | January 25, 2010 Key Record Dates |
Results First Posted: | May 19, 2014 |
Last Update Posted: | March 8, 2016 |
Last Verified: | September 2012 |
alcohol dependence PTSD propanolol craving beta-block |
cue exposure addiction memory trauma addictive behavior |
Alcoholism Mental Disorders Alcohol-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Propranolol Adrenergic beta-Antagonists Adrenergic Antagonists |
Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Arrhythmia Agents Antihypertensive Agents Vasodilator Agents |