We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Neuromodulation of Trauma Memories in PTSD & Alcohol Dependence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Medical University of South Carolina

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Alcohol Dependence
PTSD
Interventions Drug: Propranolol
Drug: Placebo
Enrollment 44
Recruitment Details  
Pre-assignment Details Participants were considered enrolled if they completed both the retrieval and testing procedure (44).
Arm/Group Title Propranolol Placebo
Hide Arm/Group Description

Patients will receive Propranolol in this condition.

Propranolol : 40 mg; Single Administration.

The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2).

Patient to receive placebo in this condition.

Placebo : 40 mg; Single Dose.

The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2)

Period Title: Overall Study
Started 29 [1] 28 [2]
Retrieval Completion 25 [3] 24 [4]
Test Procedure Completion 21 [5] 23 [6]
Completed 18 [7] 21 [8]
Not Completed 11 7
[1]
Randomized to receive medication.
[2]
Randomized to receive placebo.
[3]
Received the medication and completed the retrieval session.
[4]
Received the sugar pill and completed the retrieval session.
[5]
Received the medication and completed the first test session.
[6]
Received the placebo and completed the first test session.
[7]
Received the medication and completed all visits including the one-week follow-up.
[8]
Received the sugar pill and completed all visits including the one-week follow-up.
Arm/Group Title Propranolol Placebo Total
Hide Arm/Group Description

Patients will receive Propranolol in this condition.

Propranolol: 40 mg; Single Administration.

Patient to receive placebo in this condition.

Placebo: 40 mg; Single Dose.

Total of all reporting groups
Overall Number of Baseline Participants 21 23 44
Hide Baseline Analysis Population Description
Urn randomization was used to assign participants to the propranolol vs. placebo condition while balancing treatment assignment on gender and age (less than 35 or equal to or greater than 35 years of age).
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 21 participants 23 participants 44 participants
Greater than or equal to 35 years 14 17 31
Less than 35 years 7 6 13
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 23 participants 44 participants
Female
9
  42.9%
13
  56.5%
22
  50.0%
Male
12
  57.1%
10
  43.5%
22
  50.0%
1.Primary Outcome
Title Retrieval Session Distress Scores (Session 1)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Propranolol Placebo
Hide Arm/Group Description:

Patients will receive Propranolol in this condition.

Propranolol : 40 mg; Single Administration.

The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2).

Patient to receive placebo in this condition.

Placebo : 40 mg; Single Dose.

The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2)

Overall Number of Participants Analyzed 21 23
Mean (Standard Error)
Unit of Measure: units on a scale
54.5  (26.8) 73.9  (20.9)
2.Primary Outcome
Title Retrieval Session Craving Scores (Session 1)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Propranolol Placebo
Hide Arm/Group Description:

Patients will receive Propranolol in this condition.

Propranolol : 40 mg; Single Administration.

The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2).

Patient to receive placebo in this condition.

Placebo : 40 mg; Single Dose.

The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2)

Overall Number of Participants Analyzed 21 23
Mean (Standard Error)
Unit of Measure: units on a scale
49.1  (31.3) 71.6  (20.4)
3.Primary Outcome
Title Test Session Distress Scores (Session 2)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Propranolol Placebo
Hide Arm/Group Description:

Patients will receive Propranolol in this condition.

Propranolol : 40 mg; Single Administration.

The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2).

Patient to receive placebo in this condition.

Placebo : 40 mg; Single Dose.

The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2)

Overall Number of Participants Analyzed 21 23
Mean (Standard Error)
Unit of Measure: units on a scale
35.1  (3.7) 48.0  (3.5)
4.Primary Outcome
Title Test Session Craving Scores (Session 2)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Propranolol Placebo
Hide Arm/Group Description:

Patients will receive Propranolol in this condition.

Propranolol : 40 mg; Single Administration.

The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2).

Patient to receive placebo in this condition.

Placebo : 40 mg; Single Dose.

The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2)

Overall Number of Participants Analyzed 21 23
Mean (Standard Error)
Unit of Measure: units on a scale
51.0  (3.7) 53.9  (3.5)
5.Secondary Outcome
Title Proportion of Drinking Days
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Propranolol Placebo
Hide Arm/Group Description:

Patients will receive Propranolol in this condition.

Propranolol : 40 mg; Single Administration.

The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2).

Patient to receive placebo in this condition.

Placebo : 40 mg; Single Dose.

The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2)

Overall Number of Participants Analyzed 21 23
Mean (Standard Error)
Unit of Measure: Drinking days
42.2  (6.4) 45.9  (6.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Propranolol Placebo
Hide Arm/Group Description

Patients will receive Propranolol in this condition.

Propranolol: 40 mg; Single Administration.

Patient to receive placebo in this condition.

Placebo: 40 mg; Single Dose.

All-Cause Mortality
Propranolol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Propranolol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/26 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Propranolol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/26 (0.00%) 
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Michael Saladin
Organization: Medical University of South Carolina
Phone: 843-792-5306
EMail: saladinm@musc.edu
Layout table for additonal information
Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01055171    
Other Study ID Numbers: 19489
1RC1AA019019-01 ( U.S. NIH Grant/Contract )
First Submitted: January 21, 2010
First Posted: January 25, 2010
Results First Submitted: April 18, 2014
Results First Posted: May 19, 2014
Last Update Posted: March 8, 2016