Alcohol Abuse, Alcohol Dependence, Alcohol Use Disorder, Social Anxiety Disorder, Social Phobia
Conditions
Keywords
Pharmacotherapy, Self medication
Brief summary
The purpose of the study is to determine whether an SSRI, paroxetine, improves social anxiety symptoms and alcohol use in individuals who drink to cope with social anxiety disorder.
Detailed description
Social anxiety disorder (also known as social phobia) is an Axis I anxiety disorder characterized by intense fear and avoidance of social or performance situations in which one might be scrutinized. Its onset is typically in the early teen years. It is the third most common mental disorder in the United States, exceeded in prevalence only by depression and alcoholism. Approximately 20% of the individuals with social anxiety disorder have alcohol problems. Anecdotal and empirical evidence suggests that alcohol is used by some socially anxious individuals to self-medicate anxiety symptoms, a practice that could lead to alcohol abuse and/or dependence. The proposed project further explores the self-medication hypothesis through the use of a double-blind, randomized, placebo-controlled clinical trial. Paroxetine (a selective serotonin reuptake inhibitor) is the drug to be used in the study. Individuals who drink alcohol to cope with social anxiety symptoms and who meet DSM-IV criteria for the dual-diagnoses of social anxiety disorder and alcohol use disorders will be enrolled in the trial. All individuals will be seeking treatment for social anxiety disorder. The treatment phase will last 16 weeks. Dosing will start at 20 mg/day (paroxetine or placebo) and will increase gradually to a maximum dose of 60 mg/day. Each week during treatment and at the end of the trial, assessments will be made with standard instruments to determine the effect of paroxetine (versus placebo) on social anxiety severity, alcohol use, and more specifically, the intentional use of alcohol to cope with social anxiety symptoms. Additionally, 6 month and 12 month follow-up interviews will be conducted. The overarching hypothesis is that because paroxetine will improve social anxiety severity, alcohol use and/or alcohol use for coping will also be reduced in the paroxetine-treated group.
Interventions
DRUGParoxetine
16 weeks treatment; dosing will start at 20 mg/day paroxetine and will increase gradually to a maximum dose of 60 mg/day
DRUGPlacebo
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.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Meets DSM-IV criteria for current social anxiety disorder * Reports social anxiety in most situations (generalized type). * Treatment seeking for relief of social anxiety. * Meets DSM-IV criteria for current alcohol use disorder * Reads at the 6th grade level or above * Endorses using alcohol to cope with social anxiety either very often or always. * Reports no prior medical alcohol detoxification * Willingness to be randomized to the placebo group * Willingness to attend 16 weekly medication management visits and one alcohol-related therapy session * Liebowitz Social Anxiety Scale Total score (modified version) of at least 60 * Endorses drinking at least 15 standard drinks in a typical 30 day period or reports drinking heavily (defined as greater-than-or-equal-to 4 standard drinks on one occasion for women; greater-than-or-equal-to 5 standard drinks on one occasion for men, respectively) on at least 2 days in a typical 30 day period.
Exclusion criteria
* Abuse or dependence on drugs other than nicotine or marijuana in last 90 days * Current or past diagnosis of bipolar disorder or schizophrenia * Significant suicide risk as assessed by the SCID * Current use of psychotropic medications * Treatment seeking for alcohol problems * Any unstable medical condition that might interfere with safe participation in the trial * Elevated liver enzymes (3 x greater than normal levels) * History of adverse reaction to paroxetine * History of failure to respond to adequate trial or dose of paroxetine for social phobia (60 mg/day for at least 6 weeks) * History of heart problems or abnormal ECG recording * Pregnancy, nursing, or refusal to use effective birth control if sexually active and premenopausal * History of one or more alcohol detoxifications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Social Anxiety Severity | 16 weeks treatment | 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. |
| Alcohol Use, Quantity and Frequency | 16 weeks treatment | 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). |
| Drinking to Cope | 16 weeks treatment | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Paroxetine 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 | 20 |
| Placebo 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. | 22 |
| Total | 42 |
Baseline characteristics
| Characteristic | Placebo | Paroxetine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 20 Participants | 42 Participants |
| Age, Continuous | 30 years STANDARD_DEVIATION 8.3 | 28 years STANDARD_DEVIATION 6.5 | 29 years STANDARD_DEVIATION 7.4 |
| Region of Enrollment United States | 22 participants | 20 participants | 42 participants |
| Sex: Female, Male Female | 11 Participants | 9 Participants | 20 Participants |
| Sex: Female, Male Male | 11 Participants | 11 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 22 |
| other Total, other adverse events | 14 / 20 | 8 / 22 |
| serious Total, serious adverse events | 0 / 20 | 0 / 22 |
Outcome results
Primary
Alcohol Use, Quantity and Frequency
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paroxetine | Alcohol Use, Quantity and Frequency | PDA | .66 units on a scale | Standard Error 0.07 |
| Paroxetine | Alcohol Use, Quantity and Frequency | DDD | 5.88 units on a scale | Standard Error 1.02 |
| Paroxetine | Alcohol Use, Quantity and Frequency | PHD | .54 units on a scale | Standard Error 0.11 |
| Placebo | Alcohol Use, Quantity and Frequency | PDA | .65 units on a scale | Standard Error 0.07 |
| Placebo | Alcohol Use, Quantity and Frequency | DDD | 7.00 units on a scale | Standard Error 1.48 |
| Placebo | Alcohol Use, Quantity and Frequency | PHD | .55 units on a scale | Standard Error 0.13 |
Primary
Drinking to Cope
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paroxetine | Drinking to Cope | .35 proportion of drinking days | Standard Error 0.1 |
| Placebo | Drinking to Cope | .21 proportion of drinking days | Standard Error 0.04 |
Primary
Social Anxiety Severity
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paroxetine | Social Anxiety Severity | 87 units on a scale | Standard Deviation 14.9 |
| Placebo | Social Anxiety Severity | 93 units on a scale | Standard Deviation 18.5 |