Neuromodulation of Trauma Memories in PTSD & Alcohol Dependence

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01055171
First received: January 21, 2010
Last updated: April 18, 2014
Last verified: September 2012
Results First Received: April 18, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Alcohol Dependence
PTSD
Interventions: Drug: Propranolol
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Propranolol

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).

Placebo

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)


Participant Flow:   Overall Study
    Propranolol     Placebo  
STARTED     25 [1]   26 [2]
Retrieval Completion     21 [3]   23 [4]
COMPLETED     18 [5]   20 [6]
NOT COMPLETED     7     6  
[1] Received the medication at the test session.
[2] Received the sugar pill at the test session.
[3] Received the medication and completed both the test and retrieval sessions (Test Day 1 and 2)
[4] Received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2)
[5] Received the medication and completed all visits including the one-week follow-up.
[6] Received the sugar pill and completed all visits including the one-week follow-up.



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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).

Reporting Groups
  Description
Propranolol

Patients will receive Propranolol in this condition.

Propranolol: 40 mg; Single Administration.

Placebo

Patient to receive placebo in this condition.

Placebo: 40 mg; Single Dose.

Total Total of all reporting groups

Baseline Measures
    Propranolol     Placebo     Total  
Number of Participants  
[units: participants]
  21     23     44  
Age, Customized  
[units: Participants]
     
<=35     14     17     31  
>35     7     6     13  
Gender  
[units: Participants]
     
Female     9     13     22  
Male     12     10     22  



  Outcome Measures

1.  Primary:   Mean of the Difference of Session 1 and Session 2 Distress Scores (Session 2-Session 1).   [ Time Frame: Participants will rate their level of distress at regular intervals throughout both days of cue exposure. ]

2.  Primary:   Mean of the Difference of Session 1 and Session 2 Alcohol Craving Scores (Session 2-Session 1).   [ Time Frame: Participants will rate their level of craving at regular intervals throughout both days of cue exposure ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Michael Saladin
Organization: Medical University of South Carolina
phone: 843-792-5306
e-mail: saladinm@musc.edu


No publications provided


Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01055171     History of Changes
Other Study ID Numbers: 19489, 1RC1AA019019-01
Study First Received: January 21, 2010
Results First Received: April 18, 2014
Last Updated: April 18, 2014
Health Authority: United States: Food and Drug Administration