Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a randomized, placebo controlled, double blind crossover study of the effects of intranasal oxytocin on social cognition, implicit preferences and craving in moderate to heavy social alcohol drinkers.
Impaired social functioning is an important feature of substance use disorders. Social deficits are a risk factor for developing substance use disorders as well as a consequence of substance abuse. Improved social functioning is also a key goal of effective substance abuse treatments. While treatment of disrupted social networks is a mainstay of psychosocial substance abuse treatments, there are currently no pharmacological interventions aimed at improving social functioning in individuals with substance use disorders. Oxytocin administration may shift preference from substance related cues to social cues and may decrease subjective craving for alcohol.
The specific aims are:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxytocin | Experimental | 50 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal oxytocin. |
|
| Placebo | Placebo Comparator | 50 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal placebo. NOTE: This is a cross-over design and subjects will participate in both arms. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin | Drug | Intranasal oxytocin |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Craving on the Alcohol Urge Questionnaire (AUQ) After Administration of Oxytocin vs. Placebo During the 3-week Study. | Change in craving represented by the mean difference in Alcohol Urge Questionnaire (AUQ) craving scores between alcohol and water cues (e.g., a positive alcohol-water score indicates cue-induced craving) after administration of oxytocin vs. placebo during the 3-week study. Craving for alcohol was assessed prior to the water and alcohol cues and again after each stimulus presentation using the 8-item Alcohol Urge Questionnaire (AUQ) (Bohn et al., 1995), in which subjects indicate how much they agree or disagree with statements regarding their alcohol craving on a 7-point Likert scale. AUQ craving scores are calculated by averaging responses to the 8 items. Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7). Items 2 and 7 are reverse scored. A total score is computed by averaging the item scores and ranges from 1 to 7. Higher scores reflect greater craving. | Measured just prior to and after each of the water and alcohol cues at visits 2 and 3. |
| Measure | Description | Time Frame |
|---|---|---|
| Average Percentage of Correct Responses on a Social Perception Task, Reading the Mind in the Eyes Test (RMET) After Administration of Oxytocin vs. Placebo During the 3-week Study. | We will examine the effects of intranasal oxytocin administration on overall RMET performance in moderate to heavy social alcohol drinkers after placebo or oxytocin administration. The RMET has 28 items. Each item is an cropped photo of a person's eyes with four emotion labels around it. The subjects are asked to select which one of the four emotion words best describes the emotion that the eyes are showing. RMET is scored by adding up the total number of correct responses (range 0-28). The mean percent correct is then calculated. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Josh Woolley, MD, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ernest Gallo Clinic and Research Center | Emeryville | California | 94608 | United States |
Sixty-one nontreatment-seeking subjects were recruited online. Eligible subjects met DSM-IV criteria for alcohol abuse, but were excluded if physically dependent on alcohol. These subjects were screened to yield 39 eligible subjects. Of the 39 subjects deemed eligible, 7 did not return after the screening visit, resulting in 32 enrolled subjects.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Oxytocin First, Then Placebo | 18 moderate to heavy social alcohol users received a single dose 40 IU of intranasal oxytocin followed by a single dose 40 IU of intranasal placebo. NOTE: This is a cross-over design and subjects will participate in both arms. |
| FG001 | Placebo First Then Oxytocin | 14 moderate to heavy social alcohol users received a single dose 40 IU of intranasal placebo followed by a single dose 40 IU of intranasal oxytocin. NOTE: This is a cross-over design and subjects will participate in both arms. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Washout Period - 1 Week |
| |||||||||||||
| 2nd Intervention |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | This is a crossover study of 39 moderate to heavy social alcohol users who will receive a single dose 40 IU of intranasal oxytocin followed by 40 IU of placebo or vice versa. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Craving on the Alcohol Urge Questionnaire (AUQ) After Administration of Oxytocin vs. Placebo During the 3-week Study. | Change in craving represented by the mean difference in Alcohol Urge Questionnaire (AUQ) craving scores between alcohol and water cues (e.g., a positive alcohol-water score indicates cue-induced craving) after administration of oxytocin vs. placebo during the 3-week study. Craving for alcohol was assessed prior to the water and alcohol cues and again after each stimulus presentation using the 8-item Alcohol Urge Questionnaire (AUQ) (Bohn et al., 1995), in which subjects indicate how much they agree or disagree with statements regarding their alcohol craving on a 7-point Likert scale. AUQ craving scores are calculated by averaging responses to the 8 items. Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7). Items 2 and 7 are reverse scored. A total score is computed by averaging the item scores and ranges from 1 to 7. Higher scores reflect greater craving. | In this crossover study a total of 32 participants were analyzed for each intervention. | Posted | Mean | Standard Error | units on a 7-pt Likert Scale | Measured just prior to and after each of the water and alcohol cues at visits 2 and 3. |
Over course of 3 week study
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oxytocin | 50 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal oxytocin. Oxytocin |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Mitchell, PhD | University of California, San Francisco | 510-985-3921 | jennifer.mitchell@ucsf.edu |
Not provided
| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Intranasal placebo |
|
| Administered at visits 2 and 3 |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Oxytocin | 18 moderate to heavy social alcohol users received 40 IU of intranasal oxytocin followed by 40 IU of intranasal placebo and 14 received 40 IU of intranasal placebo first followed by 40 IU of intranasal oxytocin, for a total of 32 participants analyzed. |
| OG001 | Placebo | 14 moderate to heavy social alcohol users received 40 IU of intranasal placebo followed by 40 IU of intranasal oxytocin and 18 received 40 IU of intranasal oxytocin first followed by 40 IU of intranasal placebo, for a total of 32 participants analyzed. |
|
|
| Secondary | Average Percentage of Correct Responses on a Social Perception Task, Reading the Mind in the Eyes Test (RMET) After Administration of Oxytocin vs. Placebo During the 3-week Study. | We will examine the effects of intranasal oxytocin administration on overall RMET performance in moderate to heavy social alcohol drinkers after placebo or oxytocin administration. The RMET has 28 items. Each item is an cropped photo of a person's eyes with four emotion labels around it. The subjects are asked to select which one of the four emotion words best describes the emotion that the eyes are showing. RMET is scored by adding up the total number of correct responses (range 0-28). The mean percent correct is then calculated. | 1 subject did not complete the RMET task, so only 31 participant responses were analyzed for this task. | Posted | Mean | Standard Error | Mean percent correct responses | Administered at visits 2 and 3 |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Placebo | 50 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal placebo. NOTE: This is a cross-over design and subjects will participate in both arms. Placebo | 0 | 32 | 0 | 32 |
Not provided
Not provided
Not provided
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |