Neuromodulation of Trauma Memories in PTSD & Alcohol Dependence

• 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: Medical University of South Carolina
• 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

Participant Flow

Recruitment Details
Pre-assignment Details	Participants were considered enrolled if they completed both the retrieval and testing procedure (44).

Arm/Group Title	Propranolol	Placebo
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.

Baseline Characteristics

Arm/Group Title		Propranolol	Placebo	Total
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
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%

Outcome Measures

1. Primary Outcome

Title	Retrieval Session Distress Scores (Session 1)
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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Propranolol	Placebo
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)
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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Propranolol	Placebo
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)
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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Propranolol	Placebo
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)
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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Propranolol	Placebo
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
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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Propranolol	Placebo
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)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Propranolol	Placebo
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	--/--	--/--
Serious Adverse Events
	Propranolol	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/25 (0.00%)	0/26 (0.00%)
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%)

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.

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
• EMail: saladinm@musc.edu

• 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