Alcohol Misuse, Alcohol Use Disorder
Conditions
Brief summary
Primary: The primary objective of the study is to compare the efficacy of intranasal oxytocin in reducing the weekly percentage of heavy drinking days over the 10 weeks of maintenance treatment among subjects with moderate to severe Alcohol Use Disorder (AUD). A heavy drinking day is 4 or more drinks per drinking day for women and 5 or more drinks per drinking day for men. Secondary: Secondary objectives include assessment of other measures of the effects of oxytocin compared with placebo on reduction of alcohol use as well as effects on psychological assessments, alcohol craving, alcohol-related consequences, cigarette smoking and other nicotine use, retention in the study, safety, and application site (nares) tolerability throughout the study.
Interventions
DRUGInstranasal Oxytocin
Intranasal Oxytocin - concentrated formulation - 35 IU per dose
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Be at least 21 years of age. 2. Have a current (past 12 months) DSM-5 diagnosis of AUD (4 or more symptoms) assessed using the MINI neuropsychiatric interview version 7.0.2 (at least moderate severity, ICD-10-CM Code F10.20 alcohol dependence, uncomplicated). 3. Have a BAC by breathalyzer equal to 0.000 when s/he signed the informed consent document (either just prior to or immediately after signing consent). 4. Be seeking treatment for problems with alcohol reduction in drinking. 5. Be able to verbalize an understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English and able to complete the questionnaires required by the protocol. 6. Agree (if the subject is female and of child bearing potential) to use at least one of the following methods of birth control, unless she is surgically sterile, partner is surgically sterile or she is postmenopausal: 1. oral contraceptives, 2. contraceptive sponge, 3. patch, 4. double barrier (diaphragm/spermicidal or condom/spermicidal), 5. intrauterine contraceptive system, 6. etonogestrel implant, 7. medroxyprogesterone acetate contraceptive injection, 8. complete abstinence from sexual intercourse, and/or 9. hormonal vaginal contraceptive ring. 7. Be able to take intranasal investigational products and be willing to adhere to the investigational product regimen. 8. Complete all assessments required at screening and baseline. 9. Have a place to live in the 2 weeks prior to randomization and not be at risk that s/he will lose his/her housing by Study Week 14. 10. Not anticipate any significant problems with transportation arrangements or available time to travel to the study site by Study Week 14. 11. Not have any plans to move within Study Week 14 to a location which would make continued participation in the study impractical. 12. Not have any unresolved legal problems that could jeopardize continuation or completion of the study. 13. Provide contact information of someone, such as a family member, spouse, or significant other, who may be able to contact the subject in case of a missed clinic appointment. 14. Be someone who in the opinion of the investigator would be expected to complete the study protocol. 15. Agree to the schedule of visits, verbally acknowledge that s/he will be able to attend each scheduled visit, participate in phone visits and that s/he does not have any already scheduled events or a job that may substantially interfere with study participation. 16. If taking a medication for depression or anxiety, must have been taking a stable dose in the 2-months prior to randomization and plan to continue during the study. This includes drugs such as the following: * SSRIs * Dual uptake inhibitors * SNRIs * Tricyclic antidepressants * MAOIs * Bupropion 17. Not currently taking oxytocin and agree not to take non-study oxytocin for the duration of the study.
Exclusion criteria
Contact study site for
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weekly Percentage of Heavy Drinking Days | Weeks 3-12 | The primary efficacy endpoint is the weekly percentage of heavy drinking days during the 10-week maintenance treatment period. A heavy drinking day is 4 or more drinks per drinking day for women and 5 or more drinks per drinking day for men. Drinking data will be collected by the Timeline Followback (TLFB) method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Abstinent From Alcohol | Weeks 3-12 | Percentage of subjects abstinent from alcohol during the 10-week Maintenance period |
| Percentage of Subjects With at Least a 1-level World Health Organization (WHO) Drinking Risk Category Decrease | weeks 3-12 | Percentage of subjects with at least a 1-level World Health Organization (WHO) drinking risk category decrease from the baseline level to (the period including the 28 days before screening) to the level during the treatment phase (Study Weeks 3-12). The WHO levels of average alcohol consumption per day vary by Sex of participants and are as follows: Males Females Low Risk 1 to 40g 1 to 20g Medium Risk 41 to 60g 21 to 40g High Risk 61 to 100g 41 to 60g Very High Risk 101+g 61+g where 14g = 1 SDU (WHO-2000). In computing the WHO alcohol consumption level, average drinks per day were used, computed as the sum of all drinks in the 28 day period divided by the number of days with non-missing drinking data in that period. Abstinent subjects were included in a separate Abstinent category. |
| Percentage of Subjects With at Least a 2-level World Health Organization (WHO) Drinking Risk Category Decrease | weeks 3-12 | Percentage of subjects with at least a 2-level World Health Organization (WHO) drinking risk category decrease from the baseline level to (the period including the 28 days before screening) to the level during the treatment phase (Study Weeks 3-12). The WHO levels of average alcohol consumption per day vary by Sex of participants and are as follows: Males Females Low Risk 1 to 40g 1 to 20g Medium Risk 41 to 60g 21 to 40g High Risk 61 to 100g 41 to 60g Very High Risk 101+g 61+g where 14g = 1 SDU (WHO-2000). In computing the WHO alcohol consumption level, average drinks per day were used, computed as the sum of all drinks in the 28 day period divided by the number of days with non-missing drinking data in that period. Abstinent subjects were included in a separate Abstinent category. |
| Percentage of Days Abstinent Per Week | weeks 3-12 | Timeline Follow Back daily drinking data used to calculate the % of days abstinent per week during the 10-week Maintenance period. |
| Weekly Mean Number of Drinks Per Week | weeks 3-12 | Weekly mean number of drinks per week during the 10-week Maintenance period. |
| Weekly Mean Drinks Per Drinking Day | weeks 3-12 | Weekly mean drinks per drinking day during the 10-week Maintenance period. |
| Number of Alcohol Use Disorder Symptoms (MINI) | week 13 | The MINI (paper version 7.0.2) is a short structured diagnostic interview, developed jointly by psychiatrists and clinicians in the United States and Europe, for DSM-5 and ICD-10 psychiatric disorders (Sheehan-1998). This scale is a count of the number of alcohol use disorder symptoms. Minimum = 0 and maximum=11. Higher scores indicate worse outcome. |
| Cigarettes Smoked Per Week Among Smokers | weeks 3-12 | Cigarettes smoked per week among smokers during the 10-week Maintenance period. |
| Percentage of Subjects With no Heavy Drinking Days | weeks 3-12 | Percentage of subjects with no heavy drinking days during the 10-week Maintenance period |
| Other Nicotine Product Use - Days Per Week Among Other Nicotine Product Users | weeks 3-12 | Other nicotine product use - days per week among other nicotine product users during the Maintenance period |
| Experiences in Close Relationships-Relationship Structures Questionnaire (ECR-RS) Scores (Attachment-related Anxiety Subscale) | weeks 3-12 | Experiences in Close Relationships-Relationship Structures Questionnaire (ECR-RS) scores (attachment-related anxiety subscale) during the 10-week Maintenance period. Minimum = 0 and maximum = 126. Higher scores are worse outcome. |
| PROMIS Sleep Disturbances Score | weeks 3-12 | PROMIS® (Patient-Reported Outcomes Measurement Information System) Sleep Disturbances score (Short Form 8b) during the 10-week Maintenance period. Scores are T-scores with a mean of 50 and standard deviation of 10. Minimum = 0 and maximum = 100. Higher scores are worse outcome (i.e., more sleep disturbance). |
| PROMIS Alcohol-related Negative Consequences Score | weeks 3-12 | PROMIS® (Patient-Reported Outcomes Measurement Information System) alcohol-related negative consequences score (Long Form) during the 10-week Maintenance period. Scores are T-scores with a mean of 50 and standard deviation of 10. Minimum = 0 and maximum = 100. Higher scores are worse outcome (i.e., more alcohol-related negative consequences). |
| PROMIS Pain Interference Score | weeks 3-12 | PROMIS® (Patient-Reported Outcomes Measurement Information System) Pain Interference score (Short Form 8a) during the 10-week Maintenance period. Scores are T-scores with a mean of 50 and standard deviation of 10. Minimum = 0 and maximum = 100. Higher scores are worse outcome (i.e., more pain interference). |
| Profile of Moods States (POMS) - Total Mood Disturbance | weeks 3-12 | Profile of Moods States (POMS) - Total Mood Disturbance during the 10-week Maintenance period. Minimum = -32 and maximum = 200. Higher scores are worse outcome. |
| Urge to Drink Alcohol Craving Score | weeks 3-12 | Urge to Drink alcohol craving score during the 10-week Maintenance period. Minimum = 0 and maximum = 35. Higher scores are worse outcome. |
| Abstinence From Cigarette Smoking Among Smokers | weeks 3-12 | Abstinence from cigarette smoking among smokers during the 10-week Maintenance period. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intranasal Oxytocin Oxytocin, 35 IU per dose, intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. The total daily dose of oxytocin will be 70 IU/mL.
Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose | 49 |
| Instrasal Placebo Identically matched placebo administered intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL.
Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose | 48 |
| Total | 97 |
Baseline characteristics
| Characteristic | Intranasal Oxytocin | Instrasal Placebo | Total |
|---|---|---|---|
| Age, Continuous | 50.0 years STANDARD_DEVIATION 10.8 | 51.1 years STANDARD_DEVIATION 10.1 | 50.6 years STANDARD_DEVIATION 10.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 1 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants | 46 Participants | 88 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Percentage of heavy drinking days | 74.7 percentage of days STANDARD_DEVIATION 23 | 79.8 percentage of days STANDARD_DEVIATION 21.5 | 77.2 percentage of days STANDARD_DEVIATION 22.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 5 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 39 Participants | 42 Participants | 81 Participants |
| Region of Enrollment United States | 49 participants | 48 participants | 97 participants |
| Sex: Female, Male Female | 21 Participants | 18 Participants | 39 Participants |
| Sex: Female, Male Male | 28 Participants | 30 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 48 |
| other Total, other adverse events | 44 / 49 | 45 / 48 |
| serious Total, serious adverse events | 0 / 49 | 0 / 48 |
Outcome results
Primary
Weekly Percentage of Heavy Drinking Days
The primary efficacy endpoint is the weekly percentage of heavy drinking days during the 10-week maintenance treatment period. A heavy drinking day is 4 or more drinks per drinking day for women and 5 or more drinks per drinking day for men. Drinking data will be collected by the Timeline Followback (TLFB) method.
Time frame: Weeks 3-12
Population: Full Analysis Set - randomized and received study medication
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Oxytocin | Weekly Percentage of Heavy Drinking Days | 51.5 percentage of days per week | Standard Error 3.9 |
| Instrasal Placebo | Weekly Percentage of Heavy Drinking Days | 52.9 percentage of days per week | Standard Error 3.9 |
Secondary
Abstinence From Cigarette Smoking Among Smokers
Abstinence from cigarette smoking among smokers during the 10-week Maintenance period.
Time frame: weeks 3-12
Population: Full Analysis Set - randomized and received medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intranasal Oxytocin | Abstinence From Cigarette Smoking Among Smokers | 0 percentage of participants |
| Instrasal Placebo | Abstinence From Cigarette Smoking Among Smokers | 0 percentage of participants |
Secondary
Cigarettes Smoked Per Week Among Smokers
Cigarettes smoked per week among smokers during the 10-week Maintenance period.
Time frame: weeks 3-12
Population: Full Analysis Set - randomized and received medication
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Oxytocin | Cigarettes Smoked Per Week Among Smokers | 40.6 number of cigarettes smoked per week | Standard Deviation 32.1 |
| Instrasal Placebo | Cigarettes Smoked Per Week Among Smokers | 45.9 number of cigarettes smoked per week | Standard Deviation 52.8 |
Secondary
Experiences in Close Relationships-Relationship Structures Questionnaire (ECR-RS) Scores (Attachment-related Anxiety Subscale)
Experiences in Close Relationships-Relationship Structures Questionnaire (ECR-RS) scores (attachment-related anxiety subscale) during the 10-week Maintenance period. Minimum = 0 and maximum = 126. Higher scores are worse outcome.
Time frame: weeks 3-12
Population: Full Analysis Set - randomized and received medication
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Oxytocin | Experiences in Close Relationships-Relationship Structures Questionnaire (ECR-RS) Scores (Attachment-related Anxiety Subscale) | 2.4 score on a scale | Standard Error 0.1 |
| Instrasal Placebo | Experiences in Close Relationships-Relationship Structures Questionnaire (ECR-RS) Scores (Attachment-related Anxiety Subscale) | 2.4 score on a scale | Standard Error 0.1 |
Secondary
Number of Alcohol Use Disorder Symptoms (MINI)
The MINI (paper version 7.0.2) is a short structured diagnostic interview, developed jointly by psychiatrists and clinicians in the United States and Europe, for DSM-5 and ICD-10 psychiatric disorders (Sheehan-1998). This scale is a count of the number of alcohol use disorder symptoms. Minimum = 0 and maximum=11. Higher scores indicate worse outcome.
Time frame: week 13
Population: Full Analysis Set - randomized and received medication
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Oxytocin | Number of Alcohol Use Disorder Symptoms (MINI) | 3.9 Number of alcohol use disorder symptoms | Standard Error 0.3 |
| Instrasal Placebo | Number of Alcohol Use Disorder Symptoms (MINI) | 4.2 Number of alcohol use disorder symptoms | Standard Error 0.3 |
Secondary
Other Nicotine Product Use - Days Per Week Among Other Nicotine Product Users
Other nicotine product use - days per week among other nicotine product users during the Maintenance period
Time frame: weeks 3-12
Population: Full Analysis Set - randomized and received medication
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Oxytocin | Other Nicotine Product Use - Days Per Week Among Other Nicotine Product Users | 4.9 days per week | Standard Deviation 1.9 |
| Instrasal Placebo | Other Nicotine Product Use - Days Per Week Among Other Nicotine Product Users | 5.4 days per week | Standard Deviation 2.3 |
Secondary
Percentage of Days Abstinent Per Week
Timeline Follow Back daily drinking data used to calculate the % of days abstinent per week during the 10-week Maintenance period.
Time frame: weeks 3-12
Population: Full Analysis Set - randomized and received study medication
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Oxytocin | Percentage of Days Abstinent Per Week | 23.2 percentage of days per week | Standard Error 2.5 |
| Instrasal Placebo | Percentage of Days Abstinent Per Week | 22.6 percentage of days per week | Standard Error 2.5 |
Secondary
Percentage of Subjects Abstinent From Alcohol
Percentage of subjects abstinent from alcohol during the 10-week Maintenance period
Time frame: Weeks 3-12
Population: Full Analysis Set - randomized and received medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intranasal Oxytocin | Percentage of Subjects Abstinent From Alcohol | 0 percentage of participants |
| Instrasal Placebo | Percentage of Subjects Abstinent From Alcohol | 2.1 percentage of participants |
Secondary
Percentage of Subjects With at Least a 1-level World Health Organization (WHO) Drinking Risk Category Decrease
Percentage of subjects with at least a 1-level World Health Organization (WHO) drinking risk category decrease from the baseline level to (the period including the 28 days before screening) to the level during the treatment phase (Study Weeks 3-12). The WHO levels of average alcohol consumption per day vary by Sex of participants and are as follows: Males Females Low Risk 1 to 40g 1 to 20g Medium Risk 41 to 60g 21 to 40g High Risk 61 to 100g 41 to 60g Very High Risk 101+g 61+g where 14g = 1 SDU (WHO-2000). In computing the WHO alcohol consumption level, average drinks per day were used, computed as the sum of all drinks in the 28 day period divided by the number of days with non-missing drinking data in that period. Abstinent subjects were included in a separate Abstinent category.
Time frame: weeks 3-12
Population: Full Analysis Set - randomized and received study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intranasal Oxytocin | Percentage of Subjects With at Least a 1-level World Health Organization (WHO) Drinking Risk Category Decrease | 59.6 percentage of participants |
| Instrasal Placebo | Percentage of Subjects With at Least a 1-level World Health Organization (WHO) Drinking Risk Category Decrease | 53.2 percentage of participants |
Secondary
Percentage of Subjects With at Least a 2-level World Health Organization (WHO) Drinking Risk Category Decrease
Percentage of subjects with at least a 2-level World Health Organization (WHO) drinking risk category decrease from the baseline level to (the period including the 28 days before screening) to the level during the treatment phase (Study Weeks 3-12). The WHO levels of average alcohol consumption per day vary by Sex of participants and are as follows: Males Females Low Risk 1 to 40g 1 to 20g Medium Risk 41 to 60g 21 to 40g High Risk 61 to 100g 41 to 60g Very High Risk 101+g 61+g where 14g = 1 SDU (WHO-2000). In computing the WHO alcohol consumption level, average drinks per day were used, computed as the sum of all drinks in the 28 day period divided by the number of days with non-missing drinking data in that period. Abstinent subjects were included in a separate Abstinent category.
Time frame: weeks 3-12
Population: Full Analysis Set - randomized and received study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intranasal Oxytocin | Percentage of Subjects With at Least a 2-level World Health Organization (WHO) Drinking Risk Category Decrease | 23.4 percentage of participants |
| Instrasal Placebo | Percentage of Subjects With at Least a 2-level World Health Organization (WHO) Drinking Risk Category Decrease | 23.4 percentage of participants |
Secondary
Percentage of Subjects With no Heavy Drinking Days
Percentage of subjects with no heavy drinking days during the 10-week Maintenance period
Time frame: weeks 3-12
Population: Full Analysis Set - randomized and received medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intranasal Oxytocin | Percentage of Subjects With no Heavy Drinking Days | 2.1 percentage of participants |
| Instrasal Placebo | Percentage of Subjects With no Heavy Drinking Days | 6.3 percentage of participants |
Secondary
Profile of Moods States (POMS) - Total Mood Disturbance
Profile of Moods States (POMS) - Total Mood Disturbance during the 10-week Maintenance period. Minimum = -32 and maximum = 200. Higher scores are worse outcome.
Time frame: weeks 3-12
Population: Full Analysis Set - randomized and received medication
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Oxytocin | Profile of Moods States (POMS) - Total Mood Disturbance | 8.9 score on a scale | Standard Error 2.4 |
| Instrasal Placebo | Profile of Moods States (POMS) - Total Mood Disturbance | 7.6 score on a scale | Standard Error 2.4 |
Secondary
PROMIS Alcohol-related Negative Consequences Score
PROMIS® (Patient-Reported Outcomes Measurement Information System) alcohol-related negative consequences score (Long Form) during the 10-week Maintenance period. Scores are T-scores with a mean of 50 and standard deviation of 10. Minimum = 0 and maximum = 100. Higher scores are worse outcome (i.e., more alcohol-related negative consequences).
Time frame: weeks 3-12
Population: Full Analysis Set - randomized and received medication
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Oxytocin | PROMIS Alcohol-related Negative Consequences Score | 48.5 T-score | Standard Error 0.6 |
| Instrasal Placebo | PROMIS Alcohol-related Negative Consequences Score | 47.7 T-score | Standard Error 0.6 |
Secondary
PROMIS Pain Interference Score
PROMIS® (Patient-Reported Outcomes Measurement Information System) Pain Interference score (Short Form 8a) during the 10-week Maintenance period. Scores are T-scores with a mean of 50 and standard deviation of 10. Minimum = 0 and maximum = 100. Higher scores are worse outcome (i.e., more pain interference).
Time frame: weeks 3-12
Population: Full Analysis Set - randomized and received medication
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Oxytocin | PROMIS Pain Interference Score | 52.2 T-score | Standard Error 1 |
| Instrasal Placebo | PROMIS Pain Interference Score | 52.5 T-score | Standard Error 1 |
Secondary
PROMIS Sleep Disturbances Score
PROMIS® (Patient-Reported Outcomes Measurement Information System) Sleep Disturbances score (Short Form 8b) during the 10-week Maintenance period. Scores are T-scores with a mean of 50 and standard deviation of 10. Minimum = 0 and maximum = 100. Higher scores are worse outcome (i.e., more sleep disturbance).
Time frame: weeks 3-12
Population: Full Analysis Set - randomized and received study medication
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Oxytocin | PROMIS Sleep Disturbances Score | 51.0 T-score | Standard Error 0.7 |
| Instrasal Placebo | PROMIS Sleep Disturbances Score | 51.3 T-score | Standard Error 0.7 |
Secondary
Urge to Drink Alcohol Craving Score
Urge to Drink alcohol craving score during the 10-week Maintenance period. Minimum = 0 and maximum = 35. Higher scores are worse outcome.
Time frame: weeks 3-12
Population: Full Analysis Set - randomized and received medication
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Oxytocin | Urge to Drink Alcohol Craving Score | 13.6 score on a scale | Standard Error 0.7 |
| Instrasal Placebo | Urge to Drink Alcohol Craving Score | 13.2 score on a scale | Standard Error 0.7 |
Secondary
Weekly Mean Drinks Per Drinking Day
Weekly mean drinks per drinking day during the 10-week Maintenance period.
Time frame: weeks 3-12
Population: Full Analysis Set - randomized and received medication
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Oxytocin | Weekly Mean Drinks Per Drinking Day | 6.2 standard drinking units (SDUs) per week | Standard Error 0.3 |
| Instrasal Placebo | Weekly Mean Drinks Per Drinking Day | 6.3 standard drinking units (SDUs) per week | Standard Error 0.3 |
Secondary
Weekly Mean Number of Drinks Per Week
Weekly mean number of drinks per week during the 10-week Maintenance period.
Time frame: weeks 3-12
Population: Full Analysis Set - randomized and received medication
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Oxytocin | Weekly Mean Number of Drinks Per Week | 33.1 standard drinking units (SDUs) per week | Standard Error 2.2 |
| Instrasal Placebo | Weekly Mean Number of Drinks Per Week | 34.7 standard drinking units (SDUs) per week | Standard Error 2.3 |