Paroxetine for Comorbid Social Anxiety Disorder and Alcoholism

• ClinicalTrials.gov Identifier: NCT00246441
• Recruitment Status: Completed
• First Posted: October 30, 2005
• Results First Posted: September 27, 2018
• Last Update Posted: September 27, 2018
• 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: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Conditions: Social Anxiety Disorder; Social Phobia; Alcohol Use Disorder; Alcohol Abuse; Alcohol Dependence
• Interventions: Drug: Paroxetine; Drug: Placebo
• Enrollment: 42

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Paroxetine	Placebo
Arm/Group Description	Paroxetine Paroxetine: 16 weeks treatment; dosing will start at 20 mg/day paroxetine and will increase gradually to a maximum dose of 60 mg/day	Placebo Placebo: treatment phase will last 16 weeks; dosing will start at 20 mg/day (placebo) and will increase gradually to a maximum dose of 60 mg/day.
Period Title: Overall Study
Started	20	22
Completed	19	22
Not Completed	1	0

Baseline Characteristics

Arm/Group Title		Paroxetine	Placebo	Total
Arm/Group Description		Paroxetine Paroxetine: 16 weeks treatment; dosing will start at 20 mg/day paroxetine and will increase gradually to a maximum dose of 60 mg/day	Placebo Placebo: treatment phase will last 16 weeks; dosing will start at 20 mg/day (placebo) and will increase gradually to a maximum dose of 60 mg/day.	Total of all reporting groups
Overall Number of Baseline Participants		20	22	42
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	20 participants	22 participants	42 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	20 100.0%	22 100.0%	42 100.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	20 participants	22 participants	42 participants
		28 (6.5)	30 (8.3)	29 (7.4)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	20 participants	22 participants	42 participants
	Female	9 45.0%	11 50.0%	20 47.6%
	Male	11 55.0%	11 50.0%	22 52.4%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	20 participants	22 participants	42 participants
		20	22	42

Outcome Measures

1. Primary Outcome

Title	Social Anxiety Severity
Description	Liebowitz Social Anxiety Scale (LSAS) - each of the two subscales, Fear and Avoidance, each have a maximum possible score of 72 (range 0 to 72). The total score ranges from 0 to 144. A higher score indicates higher severity of Social Anxiety Disorder.
Time Frame	16 weeks treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Paroxetine	Placebo
Arm/Group Description:	Paroxetine Paroxetine: 16 weeks treatment; dosing will start at 20 mg/day paroxetine and will increase gradually to a maximum dose of 60 mg/day	Placebo Placebo: treatment phase will last 16 weeks; dosing will start at 20 mg/day (placebo) and will increase gradually to a maximum dose of 60 mg/day.
Overall Number of Participants Analyzed	20	22
Mean (Standard Deviation); Unit of Measure: units on a scale
	87 (14.9)	93 (18.5)

2. Primary Outcome

Title	Alcohol Use, Quantity and Frequency
Description	Timeline Followback (TLFB), a validated calendar based instrument to assess number of standard drinks consumed on each day of the trial. Baseline measures were computed using past 30 days. From the TLFB, three measures were computed: 1. Proportion of days abstinent (PDA) (the number of days when no drinking occurred, divided by the number of days in the assessment period) (minimum is 0, maximum is 1) (higher score is better), 2. Drinks per drinking day (DDD) (the mean number of standard drinks consumed on a drinking day in the assessment period) (minimum is >0, maximum is infinity) (higher score is worse), 3. Proportion of Heavy Drinking Days (PHD) (the proportion of days each assessment period that a woman consumed 4 or more standard drinks/ man consumed 5 or more standard drinks) (minimum is 0, maximum is 1) (higher score is worse).
Time Frame	16 weeks treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Paroxetine	Placebo
Arm/Group Description:	Paroxetine Paroxetine: 16 weeks treatment; dosing will start at 20 mg/day paroxetine and will increase gradually to a maximum dose of 60 mg/day	Placebo Placebo: treatment phase will last 16 weeks; dosing will start at 20 mg/day (placebo) and will increase gradually to a maximum dose of 60 mg/day.
Overall Number of Participants Analyzed	20	22
Mean (Standard Error); Unit of Measure: units on a scale
PDA	.66 (.07)	.65 (.07)
DDD	5.88 (1.02)	7.00 (1.48)
PHD	.54 (.11)	.55 (.13)

3. Primary Outcome

Title	Drinking to Cope
Description	Drinking days that were related to coping with Social Anxiety determined by the TLFB- the proportion of drinking days that were reported to be due to coping with social anxiety. Minimum value is 0, maximum value is 1 Higher is worse.
Time Frame	16 weeks treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Paroxetine	Placebo
Arm/Group Description:	Paroxetine Paroxetine: 16 weeks treatment; dosing will start at 20 mg/day paroxetine and will increase gradually to a maximum dose of 60 mg/day	Placebo Placebo: treatment phase will last 16 weeks; dosing will start at 20 mg/day (placebo) and will increase gradually to a maximum dose of 60 mg/day.
Overall Number of Participants Analyzed	20	22
Mean (Standard Error); Unit of Measure: proportion of drinking days
	.35 (.1)	.21 (.04)

Adverse Events

Time Frame	16 weeks
Adverse Event Reporting Description	We used a 32 item side effect checklist and we asked subjects about all items on the list at each study visit.
Arm/Group Title	Paroxetine	Placebo
Arm/Group Description	Paroxetine Paroxetine: 16 weeks treatment; dosing will start at 20 mg/day paroxetine and will increase gradually to a maximum dose of 60 mg/day	Placebo Placebo: treatment phase will last 16 weeks; dosing will start at 20 mg/day (placebo) and will increase gradually to a maximum dose of 60 mg/day.
All-Cause Mortality
	Paroxetine	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/20 (0.00%)	0/22 (0.00%)
Serious Adverse Events
	Paroxetine	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/20 (0.00%)	0/22 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	4%
	Paroxetine	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	14/20 (70.00%)	8/22 (36.36%)
Musculoskeletal and connective tissue disorders
myoclonus †	7/20 (35.00%)	1/22 (4.55%)
Nervous system disorders
tremor †	9/20 (45.00%)	3/22 (13.64%)
Reproductive system and breast disorders
anorgasmia †	11/20 (55.00%)	4/22 (18.18%)
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Dr. Sarah Book
• Organization: MUSC
• Phone: 8437925200
• EMail: booksw@musc.edu

• Responsible Party: Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT00246441
• Other Study ID Numbers: NIAAARAN013379; R01AA013379 ( U.S. NIH Grant/Contract )
• First Submitted: October 28, 2005
• First Posted: October 30, 2005
• Results First Submitted: July 23, 2018
• Results First Posted: September 27, 2018
• Last Update Posted: September 27, 2018