Sex Differences in Risk for Alcohol Abuse
- Registration Number
- NCT04543942
- Lead Sponsor
- Mark Fillmore
- Brief Summary
This study will determine the neural and hormonal mechanisms underlying sex differences in sensitivity to the disinhibiting effects of alcohol in heavy drinkers.
- Detailed Description
Alcohol abuse inflicts enormous physical, emotional, and financial burdens on the individual and society at large. Knowing who is at risk for alcohol abuse, and why, is crucial for the development of effective prevention and treatment strategies. Alcohol abuse has been traditionally considered a male-oriented problem and as a consequence research on risk factors specific to women has been minimal. However, the sex gap in substance abuse is closing rapidly, and findings from both animal and human studies suggest that females are actually more vulnerable to drug use than males. As such, there is an urgent need to identify sex differences in risk factors for alcohol abuse in order to develop sex-specific prevention and treatment efforts. One clear candidate risk factor is poor inhibitory control, both in terms of baseline levels of inhibition and sensitivity to the disinhibiting effects of alcohol. Recent studies suggest that sex hormones affect inhibitory control in drug-free individuals, potentially contributing to sex differences in baseline levels of inhibition. However, the degree to which fluctuations in sex hormones influence sex differences in inhibition-related brain function in sober and intoxicated individuals is not known. The proposed project will determine the neural and hormonal mechanisms underlying sex differences in sensitivity to the disinhibiting effects of alcohol in heavy drinkers.
The overall objective of the research is to identify hormonal determinants of alcohol effects on brain activation during response inhibition (BARI) in young adult female and male drinkers. BARI will be assessed using functional magnetic resonance imaging (fMRI) during performance of the stop signal task. This task reliably activates right-lateralized prefrontal regions implicated in inhibitory control. This study will assess BARI during IV alcohol (60mg%) and saline infusion in women during the early follicular and mid-luteal phases and in men at matched intervals.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
- heavy drinking
- Alcohol Use Disorder Identification Test score above 7
- right-handed
- BMI between 19 and 26
- high school education
- fluent in English
- women must have regular menstrual cycles
- not using hormonal contraceptives
- drug use disorder (SCID, DSM-5), other than nicotine or caffeine
- meets withdrawal criteria
- history of physical or psychiatric disease
- contraindication for fMRI
- pregnant or breastfeeding
- smoking more than 5 cigarettes per day
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Saline, then alcohol, then saline, then alcohol Saline Participants first received saline intravenously and then 24-48 hours later they received alcohol (60mg%) intravenously. Two weeks later, they again received saline intravenously and then 24 - 48 hours later they received alcohol (60mg%) intravenously. Alcohol, then saline, then alcohol, then saline Alcohol Participants first received alcohol (60mg%) intravenously and then 24-48 hours later they received saline intravenously. Two weeks later, they again received alcohol (60mg%) intravenously and then 24 - 48 hours later they received saline intravenously. Alcohol, then saline, then alcohol, then saline Saline Participants first received alcohol (60mg%) intravenously and then 24-48 hours later they received saline intravenously. Two weeks later, they again received alcohol (60mg%) intravenously and then 24 - 48 hours later they received saline intravenously. Saline, then alcohol, then saline, then alcohol Alcohol Participants first received saline intravenously and then 24-48 hours later they received alcohol (60mg%) intravenously. Two weeks later, they again received saline intravenously and then 24 - 48 hours later they received alcohol (60mg%) intravenously.
- Primary Outcome Measures
Name Time Method Brain Activation During Response Inhibition (BARI) - Saline Infusion During two saline (placebo) sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two saline sessions are averaged together Brain activation during response inhibition (BARI) was assessed using blood oxygenation level dependent (BOLD) fMRI during performance of the stop signal task during saline infusion. Values were determined by the contrast of BOLD activation during successful inhibition trials relative to go trials.
Brain Activation During Response Inhibition (BARI) - Alcohol Infusion During two alcohol sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two alcohol sessions are averaged together Brain activation during response inhibition (BARI) was assessed using blood oxygenation level dependent (BOLD) fMRI during performance of the stop signal task during alcohol (60mg%) infusion. Values were determined by the contrast of BOLD activation during successful inhibition trials relative to go trials.
- Secondary Outcome Measures
Name Time Method Estradiol Levels - Alcohol Infusion During two alcohol sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two alcohol sessions are averaged together Estradiol levels (pg/mL) were measured from blood samples following alcohol infusion.
Estradiol Levels - Saline Infusion During two saline (placebo) sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two saline sessions are averaged together Estradiol levels (pg/mL) were measured from blood samples following saline infusion.
Progesterone Levels - Alcohol Infusion During two alcohol sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two alcohol sessions are averaged together Progesterone levels (ng/mL) were measured from blood samples prior to alcohol infusion.
Progesterone Levels - Saline Infusion During two saline (placebo) sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two saline sessions are averaged together Progesterone levels (ng/mL) were measured from blood samples following saline infusion.
Testosterone Levels - Alcohol Infusion During two alcohol sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two alcohol sessions are averaged together Testosterone levels (ng/dL) were measured from blood samples following alcohol infusion.
Testosterone Levels - Saline Infusion During two saline (placebo) sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two saline sessions are averaged together Testosterone levels (ng/dL) were measured from blood samples following saline infusion.
Biphasic Alcohol Effects Score - Stimulation - Alcohol Infusion During two alcohol sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two alcohol sessions are averaged together The Biphasic Alcohol Effects Scale (BAES) is a 14-point self-reporting, unipolar adjective rating scale designed to measure both stimulant and sedative effects of alcohol. Scores range from 0-10 for each of the 7 Stimulation sub-scale questions, for a total Stimulation score range of 0-70. Higher scores indicate increased stimulation. This outcome measure was collected during alcohol (60mg%) infusion.
Biphasic Alcohol Effects Score - Sedation - Alcohol Infusion During two alcohol sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two alcohol sessions are averaged together The Biphasic Alcohol Effects Scale (BAES) is a 14-point self-reporting, unipolar adjective rating scale designed to measure both stimulant and sedative effects of alcohol. Scores range from 0-10 for each of the 7 Sedation sub-scale questions, for a total Sedation score range of 0-70. Higher scores indicate increased sedation. This outcome measure was collected during alcohol (60mg%) infusion.
Biphasic Alcohol Effects Scale (BAES) - Stimulation - Saline Infusion During two saline (placebo) sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two saline sessions are averaged together The Biphasic Alcohol Effects Scale (BAES) is a 14-point self-reporting, unipolar adjective rating scale designed to measure both stimulant and sedative effects of alcohol. Scores range from 0-10 for each of the 7 Stimulation sub-scale questions, for a total Stimulation score range of 0-70. Higher scores indicate increased stimulation. This outcome measure was collected during saline infusion.
Biphasic Alcohol Effects Scale (BAES) - Sedation - Saline During two saline (placebo) sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two saline sessions are averaged together The Biphasic Alcohol Effects Scale (BAES) is a 14-point self-reporting, unipolar adjective rating scale designed to measure both stimulant and sedative effects of alcohol. Scores range from 0-10 for each of the 7 Sedation sub-scale questions, for a total Sedation score range of 0-70. Higher scores indicate increased stimulation. This outcome measure was collected during saline infusion.
Drug Effects Questionnaire Score - Feel - Alcohol Infusion During two alcohol sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two alcohol sessions are averaged together The Drug Effects Questionnaire (DEQ) consists of four questions to assess acute subjective response to alcohol intake. This measure captures the amount someone feels the effects of alcohol, on a scale from 0 to 100. Higher scores indicate greater levels of 'feel alcohol'. Scores were obtained during alcohol (60mg%) infusion.
Drug Effects Questionnaire Score - Like - Alcohol Infusion During two alcohol sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two alcohol sessions are averaged together The Drug Effects Questionnaire (DEQ) consists of four questions to assess acute subjective response to alcohol intake. This measure captures the amount someone likes the effects of alcohol, on a scale from 0 to 100. Higher scores indicate greater levels of 'like alcohol'. Scores were obtained during alcohol (60mg%) infusion.
Drug Effects Questionnaire (DEQ) - Feel - Saline Infusion During two saline (placebo) sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two saline sessions are averaged together The Drug Effects Questionnaire (DEQ) consists of four questions to assess acute subjective response to alcohol intake. This measure captures the amount someone feels the effects of alcohol, on a scale from 0 to 100. Higher scores indicate greater levels of 'feel alcohol'. Scores were obtained during saline infusion.
Drug Effects Questionnaire (DEQ) - Like - Saline Infusion During two saline (placebo) sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two saline sessions are averaged together The Drug Effects Questionnaire (DEQ) consists of four questions to assess acute subjective response to alcohol intake. This measure captures the amount someone likes the effects of alcohol, on a scale from 0 to 100. Higher scores indicate greater levels of 'like alcohol'. Scores were obtained during saline infusion.
Trial Locations
- Locations (1)
University Of Kentucky Psychology Research Lab
🇺🇸Lexington, Kentucky, United States