Alcoholic IntoxicationPhase 1NCT00713492
Computer-Assisted Self-Administration of Ethanol
A Phase 1 study testing Alcohol in people with Alcoholic Intoxication, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
Trial summary
This study will test the reliability of a procedure for self-administering ethanol (alcohol) intravenously (through a vein), using a computer-assisted method. People ordinarily self-administer alcohol through drinking alcoholic beverages, but blood alcohol levels resulting from drinking vary greatly among individuals. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcoholic Intoxication
- What is being tested?
- Alcohol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2008to 11 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female participants between 21-45 years of age.
- Good health as determined by normal or non-clinically-significant findings on medical history, physical exam, ECG and lab tests.
- Female participants will be tested during the follicular phase of their cycle (within 10 days of offset of menses) and must have a negative urine pregnancy (hCG) test at the start of each study session. For Group 5, due to the number of study visits, female subjects will be tested outside the menses phase of their cycle.
- Group 5 will include 20 subjects who report at least 2 binge drinking episodes in the month prior to the study (a binge episode is defined as consuming at least 4 drinks for females and at least 5 drinks for males during the drinking episode) and 20 subjects
- who report no binge drinking episodes in the past month.
- Male and female participants between 21-60 years of age.
Show all 9Show fewer
- Male participants must have consumed an average of 15 or more standard drinks per week and females must have consumed an average of 8 or more standard drinks per week during the past 90 days. Average number of drinks per week will be calculated based on total number of drinks as measured by the timeline followback (TLFB) (e.g., for 90 days worth of data, total drinks divided by 90 and then multiplied by 7 will be the average number of drinks per week).
- Participants must have on average at least 1 binge drinking day per week during the last 90 days, defined as a day in which 4 or more standard drinks were consumed for females and 5 or more standard drinks were consumed for males. Average number of binge drinking days will be calculated based on total number of binge drinking days from the TLFB (e.g. for 90 days worth of data, participants with a total of 13 or more binge drinking days will be eligible).
- Participants must be able and willing to refrain from consuming alcohol 24 hours prior to each alcohol self-administration session.
Who cannot join
- Current or prior history of serious medical illness, including CNS, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, or reproductive disorders.
- Positive hepatitis A, B antigen or C or HIV test at screening.
- Current history of Axis-I psychiatric illness.
- Current or lifetime diagnosis of alcohol or substance dependence.
- Currently seeking treatment for alcohol use disorders.
- History of significant withdrawal symptoms or presence of clinically significant withdrawal symptoms (Clinical Institute Withdrawal Assessment (CIWA) score > 8) at screening.
Show all 31Show fewer
- Non-drinkers (alcohol-na(SqrRoot) ve individuals or current abstainers) or individuals with no experience drinking 5 or more drinks on one occasion in their lifetime.
- Regular tobacco users will be excluded from the study in order to avoid nicotine withdrawal symptoms. Occasional use of tobacco products (up to 20 cigarettes/week) is acceptable. For Groups 3, 4 and 5, participants must be current non-smokers (past smokers who have quit for over 1 year can be included).
- Positive result on urine drug screen or positive breathalyzer during screening visit or at the start of any study visit.
- Pregnancy or intention to become pregnant for women. Female participants will undergo a urine beta-hCG test to ensure they are not pregnant.
- Use of prescription or OTC medications known to interact with alcohol within 2 weeks of the study. These include, but may not be limited to: isosorbide, nitroglycerine, benzodiazepines, warfarin, anti-depressants such as amitriptyline, clomipramine and nefazodone, anti-diabetes medications such as glyburide, metformin and tolbutamide, H2-antagonists for heartburn such as cimetidine and
- ranitidine, muscle relaxants, anti-epileptics including phenytoin and phenobarbital codeine, and narcotics including propoxyphene, oxycodone and hydrocodone. Drugs known to inhibit or induce enzymes that metabolize alcohol should not be used for 4 weeks prior to the study. These include chlorzoxazone, isoniazid, metronidazole and disulfiram. Cough-and-cold preparations which contain anti-histamines, pain medicines and anti-inflammatories such as aspirin, ibuprofen, acetaminophen, celecoxib and naproxen, should be withheld for at least 72 hours prior to each study session.
- Current or prior history of alcohol-induced flushing reactions.
- Female participants who have abnormal menstrual cycles in the absence of irregularities caused by hormonal contraception, as defined by irregularities in menstrual cycle length (cycles of >36 days or < 8 cycles per year), clinically significant menstrual periods that are heavier or lighter than usual, and/or accompanied by significant pain, cramping or nausea and vomiting that requires intervention.
- GROUP 6
- Group 6 will include heavy drinkers between the ages of 21 and 60 years, in good health. Unfortunately, heavy drinking does not have a universally agreed upon definition and the criteria used to define heavy drinking vary from study to study. There is evidence that
- incorporating both amount of alcohol consumed per occasion and amount of alcohol consumed per week is relevant to account for risk related to pattern of drinking and total consumption. Therefore in our study we will select heavy drinkers using a definition that takes into account both pattern of drinking and total consumption. For pattern of drinking, we will require our subjects to have on average at least one binge drinking day per week, using the NIAAA definition of 5 or more drinks for men and 4 or more drinks for women (NIAAA website). For total consumption, we will use an average of 8 or more drinks per week for women and 15 or more drinks per week for men as this level of drinking has been shown to confer increased risk of mortality.
- Current or prior history of serious medical illness, including CNS, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, or reproductive disorders.
- Positive hepatitis A, B antigen, or C or HIV test at screening.
- Abnormal findings on ECG, unless cleared for participation by cardiologist or Licensed Independent Practitioner (LIP).
- Current history of major depressive disorder, bipolar disorder, psychotic disorder, obsessive compulsive disorder (OCD), post-traumatic stress disorder (PTSD), eating disorder, or any other Axis-I psychiatric disorders requiring intervention.
- An aspartate transaminase (AST) or alanine transaminase (ALT) level more than 3 times the upper limit of normal.
- Current (past 12 months) diagnosis of substance use disorder other than alcohol use disorder, unless in early remission (no criteria met for at least 3 months).
- Positive result on urine drug screen or breathalyzer test during initial or update visit under the screening protocol (14-AA-0181) most proximal to enrollment. Positive urine drug screen during more than 1 study visit or breathalyzer reading during more than 1 self-administration study visit will result in participant withdrawal from the study.
- Currently seeking treatment for alcohol use disorder or having undergone inpatient or outpatient detoxification or treatment for alcohol problems in the past 6 months.
- History of significant withdrawal symptoms or presence of clinically significant withdrawal symptoms (Clinical Institute Withdrawal Assessment (CIWA) score > 8) at screening.
- Pregnancy, intention to become pregnant, or breastfeeding. Female participants will undergo a urine beta-hCG test to ensure that they are not pregnant.
- Medication exclusion criteria:
- . Daily or regular use of prescription or OTC medications known to interact with alcohol in the 2-week period prior to assessment. These include, but may not be limited to: isosorbide, nitroglycerine, benzodiazepines, warfarin, anti-depressants such as amitriptyline, clomipramine and nefazodone, anti-diabetes medications such as glyburide, metformin and tolbutamide, H2-antagonists for heartburn such as cimetidine and ranitidine, muscle relaxants, anti-epileptics including phenytoin and phenobarbital codeine, and narcotics including propoxyphene, oxycodone and hydrocodone.
- Daily or regular use of drugs known to inhibit or induce enzymes that metabolize alcohol in the 4-week period prior to assessment. These include chlorzoxazone, isoniazid, metronidazole and disulfiram. Note that any discontinuation of medications will only be done at the recommendation of a physician.
- Current or prior history of alcohol-induced flushing reactions.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Computer-Assisted Self-Administration of Ethanol (CASE) in Humans
This study will test the reliability of a procedure for self-administering ethanol (alcohol) intravenously (through a vein), using a computer-assisted method. People ordinarily self-administer alcohol through drinking alcoholic beverages, but blood alcohol levels resulting from drinking vary greatly among individuals. For research on alcohol dependence and treatment, a tool for achieving precise blood levels is needed. In addition to testing this method of alcohol administration, the study will examine self-administration behavior and resulting breath alcohol concentration, the effects of alcohol on the participants, and differences between men and women in alcohol self-administration.
Healthy normal volunteers between 21 and 45 years of age may be eligible for this study. Participants are assigned to one of two study groups. Group 1 undergoes three 7-hour study sessions and group 2 participates in two sessions, each of which includes the following procedures:
Read more
- Breathalyzer and urine tests for alcohol and illicit drug use.
- Urine pregnancy test for women.
- Light lunch.
- Questionnaire about health and recent drinking.
Alcohol infusion: Subjects are seated in a comfortable chair and instructed on how to use a computer to give themselves a short infusion of alcohol through a catheter (plastic tube) that has been inserted into a vein in their the arm. Sensors are placed on their chest to monitor heart beat and their neck to record skin blood flow. At the start of the session, subjects complete questionnaires about any drug effects and urges to drink they may be feeling. They are trained on how to use the computer to administer alcohol and are then allowed to self-administer alcohol through the catheter any time they like, as long as their peak breath alcohol level does not exceed 0.1 g% (a level that would result from ingestion of 4 to 6 drinks in most people). If that point is reached, the computer automatically inactivates self-administration until the level is lowered again. Breathalyzer readings are taken every 15 to 30 minutes. Subjects may read, watch television or videos or listen to music during the sessions.
Recovery: At the end of the 2.5 hours of self-administration, the catheter is removed and subjects can eat, read, watch television and relax in the clinic until their breath alcohol level falls below 0.02 g%, usually after 2.5 to 3 hours, when they can go home by taxi or with a pre-arranged designated driver.
Read the detailed description
Objective: The goal of this project is to characterize the computer-assisted self-administration of ethanol (CASE) paradigm by assessing intravenous (IV) alcohol self-administration behavior and the resulting breath alcohol concentration (BrAC) exposure and pharmacologic responses in humans. The study will also evaluate the test-retest reliability of alcohol self-administration and examine the influence of sex and recent drinking history, as well as the effect of acute stress cues on alcohol self-administration. Additionally, this study will test whether a novel experimental paradigm can be used to evaluate impaired control in
heavy drinkers.
Study population: Participants will be 21-60 year-old male and female social drinkers, binge drinkers and heavy drinkers in good health, as determined by medical history, physical exam, ECG and lab tests. Participants with Axis-I psychiatric illness (other than alcohol use disorder for Group 6) will be excluded.
Design: The CASE system utilizes a model-based algorithm based on previously published methods to achieve and maintain pre-determined BrACs using IV alcohol infusions. The CASE system provides flexibility to participants in choosing when to push a button to receive alcohol, as well as flexibility to investigators in controlling the subsequent BrAC exposure. The CASE system allows the investigator to specify and assure the same BrAC increment across all participants, and is set up to prevent the BrAC from exceeding any pre-set upper limit (e.g., 120 mg%).
Following screening, participants will undergo IV ethanol self-administration sessions. Participants will be enrolled in six groups: Group 1 will consist of the first 10 participants who will participate in 3 self-administration sessions (a training session followed by 2 test sessions) to assess the test-retest reliability of alcohol self-administration behavior. Group 2 will consist of 50 participants, who will each participate in 2 self-administration sessions (a training session followed by a test session). During each session, participants will first undergo a directed priming period, lasting 25 min, where they will be prompted to push a button to receive small standardized alcohol infusions. This will be followed by an ad-lib period, lasting up to 2 hrs, where they will have free access to standardized IV alcohol infusions. During the session, BrAC will be measured, heart-rate will be continuously recorded, and subjective perceptions of alcohol effects and urges will be assessed. Group 3 will consist of 15 participants, who will undergo two identical progressive work self-administration sessions for evaluation of test-retest reliability. During each progressive ratio (PR) schedule session, participants will be required to push the button progressively higher number of times for each subsequent alcohol infusion over a 2.5 hr period. Group 4 will consist of 100 participants, who will each participate in 2 sessions: one ad lib self-administration session and one PR schedule self-administration session. Group 5 will consist of 40 participants, who will undergo a baseline self-administration session followed by an interview session for construction of guided imagery scripts. Following this, participants will undergo three alcohol self-administration sessions, following exposure to personalized stress-, alcohol- or neutral-condition associated scripts, presented in randomized order on separate days. Group 6a will consist of a maximum of 15 participants who will undergo a baseline self-administration session followed by an experimental session in which they will be given the opportunity to resist receiving self-infusions of alcohol in return for monetary reinforcers. Group 6b will consist of 37 participants who will complete a baseline self-administration session followed by two experimental sessions, with and without a priming dose of alcohol, and two follow up visits. Group 6 participants will also be given an ecological momentary assessment (EMA) device and will complete random assessments of real-world measures of impaired control and alcohol consumption per day for the duration of the study.
Outcome measures: The primary endpoint is the BrAC exposure (highest BrAC, average BrAC, area-under-the-BrAC-time-curve) achieved during the self-administration session. Additionally, changes in subjective perceptions of alcohol effects, as well as changes in heart rate will be evaluated. The influence of sex and recent drinking history as well as genetic polymorphisms on the self-administration of alcohol will also be examined. Furthermore, individual-specific cellular responses to alcohol exposure will be examined using induced pluripotent stem cells (iPSCs) from participants selected based on genotypic and phenotypic variation in self-administration measures. Outcome measures for group 5 will include stress and alcohol cue-induced craving and self-administration. Human laboratory outcome
measures for Group 6 will include time to lapse during the delay phase, number of infusions,
peak BrAC, and average BrAC during the ad-libitum phase. EMA outcomes will include
total alcohol consumption, number of impaired control episodes, and severity of impaired
control episodes. The CASE paradigm can be a valuable tool for evaluating determinants that may underlie self-administration behavior in humans. The effect of pharmacological agents on alcohol self-administration can be evaluated as a marker of the clinical effectiveness of these agents in the treatment of alcohol-dependence.
- Conditions
- Alcoholic Intoxication
- Being tested
- Alcohol
- Keywords
- Alcohol, SELF-ADMINISTRATION, Intoxication
- Medical subject headings
- Alcoholic Intoxication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlcoholDrug
human laboratory alcohol consumption.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Alcohol Receives: Drug: Alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
BrAC Exposure (peak BrAC, Average BrAC) during self-administration
alcohol consumption measured during human lab session.
Measured: 2.5 hrs
Secondary outcomes (1)
Subjective response during self-administration
alcohol consumption measured during human lab session.
Measured: 2.5 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2008 (estimated)
- Study start29 Oct 2008
- Primary completion11 Dec 2023
- Study completion11 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alcoholic IntoxicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Vijay A Ramchandani, Ph.D., Principal investigator, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00713492
- Sponsor's protocol ID
- 080178
- Other IDs
- 08-AA-0178
- Status last verified
- 6 Oct 2026
- First submitted
- 10 Jul 2008
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Sloan ME, Grant CW, Stangl BL, Klepp TD, Brewton HW, Cinar R, Kunos G, Ramchandani VA. The effects of acute alcohol administration on circulating endocannabinoid levels in humans. Addict Biol. 2022 Sep;27(5):e13197. doi: 10.1111/adb.13197.
PubMed 36001429Vatsalya V, Stangl BL, Ramchandani VA. Assessment of Skin Blood Flow Following Acute Intravenous Alcohol, and Association with Subjective Perceptions, in Social Drinkers. Alcohol Clin Exp Res. 2019 Mar;43(3):405-410. doi: 10.1111/acer.13962. Epub 2019 Feb 8.
PubMed 30735255Gowin JL, Sloan ME, Stangl BL, Vatsalya V, Ramchandani VA. Vulnerability for Alcohol Use Disorder and Rate of Alcohol Consumption. Am J Psychiatry. 2017 Nov 1;174(11):1094-1101. doi: 10.1176/appi.ajp.2017.16101180. Epub 2017 Aug 4.
PubMed 28774194
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-Assisted Self-Administration of Ethanol (CASE) in Humans
- ClinicalTrials.gov ID
- NCT00713492
- Acronym / sponsor ID
- 080178
- Conditions
- Alcoholic Intoxication
- Keywords
- Alcohol, SELF-ADMINISTRATION, Intoxication
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)US National Institutes of Health
- Study start
- 29 Oct 2008 (actual)
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- 11 Dec 2023 (actual)
- First posted
- 11 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the reliability of a procedure for self-administering ethanol (alcohol) intravenously (through a vein), using a computer-assisted method. People ordinarily self-administer alcohol through drinking alcoholic beverages, but blood alcohol levels resulting from drinking vary greatly among individuals. For research on alcohol dependence and treatment, a tool for achieving precise blood levels is needed. In addition to testing this method of alcohol administration, the study will examine self-administration behavior and resulting breath alcohol concentration, the effects of alcohol on the participants, and differences between men and women in alcohol self-administration.
Healthy normal volunteers between 21 and 45 years of age may be eligible for this study. Participants are assigned to one of two study groups. Group 1 undergoes three 7-hour study sessions and group 2 participates in two sessions, each of which includes the following procedures:
- Breathalyzer and urine tests for alcohol and illicit drug use.
- Urine pregnancy test for women.
- Light lunch.
- Questionnaire about health and recent drinking.
Alcohol infusion: Subjects are seated in a comfortable chair and instructed on how to use a computer to give themselves a short infusion of alcohol through a catheter (plastic tube) that has been inserted into a vein in their the arm. Sensors are placed on their chest to monitor heart beat and their neck to record skin blood flow. At the start of the session, subjects complete questionnaires about any drug effects and urges to drink they may be feeling. They are trained on how to use the computer to administer alcohol and are then allowed to self-administer alcohol through the catheter any time they like, as long as their peak breath alcohol level does not exceed 0.1 g% (a level that would result from ingestion of 4 to 6 drinks in most people). If that point is reached, the computer automatically inactivates self-administration until the level is lowered again. Breathalyzer readings are taken every 15 to 30 minutes. Subjects may read, watch television or videos or listen to music during the sessions.
Recovery: At the end of the 2.5 hours of self-administration, the catheter is removed and subjects can eat, read, watch television and relax in the clinic until their breath alcohol level falls below 0.02 g%, usually after 2.5 to 3 hours, when they can go home by taxi or with a pre-arranged designated driver.
Detailed description
Objective: The goal of this project is to characterize the computer-assisted self-administration of ethanol (CASE) paradigm by assessing intravenous (IV) alcohol self-administration behavior and the resulting breath alcohol concentration (BrAC) exposure and pharmacologic responses in humans. The study will also evaluate the test-retest reliability of alcohol self-administration and examine the influence of sex and recent drinking history, as well as the effect of acute stress cues on alcohol self-administration. Additionally, this study will test whether a novel experimental paradigm can be used to evaluate impaired control in
heavy drinkers.
Study population: Participants will be 21-60 year-old male and female social drinkers, binge drinkers and heavy drinkers in good health, as determined by medical history, physical exam, ECG and lab tests. Participants with Axis-I psychiatric illness (other than alcohol use disorder for Group 6) will be excluded.
Design: The CASE system utilizes a model-based algorithm based on previously published methods to achieve and maintain pre-determined BrACs using IV alcohol infusions. The CASE system provides flexibility to participants in choosing when to push a button to receive alcohol, as well as flexibility to investigators in controlling the subsequent BrAC exposure. The CASE system allows the investigator to specify and assure the same BrAC increment across all participants, and is set up to prevent the BrAC from exceeding any pre-set upper limit (e.g., 120 mg%).
Following screening, participants will undergo IV ethanol self-administration sessions. Participants will be enrolled in six groups: Group 1 will consist of the first 10 participants who will participate in 3 self-administration sessions (a training session followed by 2 test sessions) to assess the test-retest reliability of alcohol self-administration behavior. Group 2 will consist of 50 participants, who will each participate in 2 self-administration sessions (a training session followed by a test session). During each session, participants will first undergo a directed priming period, lasting 25 min, where they will be prompted to push a button to receive small standardized alcohol infusions. This will be followed by an ad-lib period, lasting up to 2 hrs, where they will have free access to standardized IV alcohol infusions. During the session, BrAC will be measured, heart-rate will be continuously recorded, and subjective perceptions of alcohol effects and urges will be assessed. Group 3 will consist of 15 participants, who will undergo two identical progressive work self-administration sessions for evaluation of test-retest reliability. During each progressive ratio (PR) schedule session, participants will be required to push the button progressively higher number of times for each subsequent alcohol infusion over a 2.5 hr period. Group 4 will consist of 100 participants, who will each participate in 2 sessions: one ad lib self-administration session and one PR schedule self-administration session. Group 5 will consist of 40 participants, who will undergo a baseline self-administration session followed by an interview session for construction of guided imagery scripts. Following this, participants will undergo three alcohol self-administration sessions, following exposure to personalized stress-, alcohol- or neutral-condition associated scripts, presented in randomized order on separate days. Group 6a will consist of a maximum of 15 participants who will undergo a baseline self-administration session followed by an experimental session in which they will be given the opportunity to resist receiving self-infusions of alcohol in return for monetary reinforcers. Group 6b will consist of 37 participants who will complete a baseline self-administration session followed by two experimental sessions, with and without a priming dose of alcohol, and two follow up visits. Group 6 participants will also be given an ecological momentary assessment (EMA) device and will complete random assessments of real-world measures of impaired control and alcohol consumption per day for the duration of the study.
Outcome measures: The primary endpoint is the BrAC exposure (highest BrAC, average BrAC, area-under-the-BrAC-time-curve) achieved during the self-administration session. Additionally, changes in subjective perceptions of alcohol effects, as well as changes in heart rate will be evaluated. The influence of sex and recent drinking history as well as genetic polymorphisms on the self-administration of alcohol will also be examined. Furthermore, individual-specific cellular responses to alcohol exposure will be examined using induced pluripotent stem cells (iPSCs) from participants selected based on genotypic and phenotypic variation in self-administration measures. Outcome measures for group 5 will include stress and alcohol cue-induced craving and self-administration. Human laboratory outcome
measures for Group 6 will include time to lapse during the delay phase, number of infusions,
peak BrAC, and average BrAC during the ad-libitum phase. EMA outcomes will include
total alcohol consumption, number of impaired control episodes, and severity of impaired
control episodes. The CASE paradigm can be a valuable tool for evaluating determinants that may underlie self-administration behavior in humans. The effect of pharmacological agents on alcohol self-administration can be evaluated as a marker of the clinical effectiveness of these agents in the treatment of alcohol-dependence.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AlcoholAlcohol |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male and female participants between 21-45 years of age.
- Good health as determined by normal or non-clinically-significant findings on medical history, physical exam, ECG and lab tests.
- Female participants will be tested during the follicular phase of their cycle (within 10 days of offset of menses) and must have a negative urine pregnancy (hCG) test at the start of each study session. For Group 5, due to the number of study visits, female subjects will be tested outside the menses phase of their cycle.
- Group 5 will include 20 subjects who report at least 2 binge drinking episodes in the month prior to the study (a binge episode is defined as consuming at least 4 drinks for females and at least 5 drinks for males during the drinking episode) and 20 subjects
- who report no binge drinking episodes in the past month.
Key exclusion criteria (31 listed)
- Current or prior history of serious medical illness, including CNS, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, or reproductive disorders.
- Positive hepatitis A, B antigen or C or HIV test at screening.
- Current history of Axis-I psychiatric illness.
- Current or lifetime diagnosis of alcohol or substance dependence.
- Currently seeking treatment for alcohol use disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcoholhuman laboratory alcohol consumption. | Drug | 1 |
Primary outcome
BrAC Exposure (peak BrAC, Average BrAC) during self-administration
Time frame: 2.5 hrs
alcohol consumption measured during human lab session.
1 secondary outcome
Subjective response during self-administration
Time frame: 2.5 hrs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Derived from this study: PubMed 36001429Sloan ME, Grant CW, Stangl BL, Klepp TD, Brewton HW, Cinar R, Kunos G, Ramchandani VA. The effects of acute alcohol administration on circulating endocannabinoid levels in humans. Addict Biol. 2022 Sep;27(5):e13197. doi: 10.1111/adb.13197.
- Derived from this study: PubMed 30735255Vatsalya V, Stangl BL, Ramchandani VA. Assessment of Skin Blood Flow Following Acute Intravenous Alcohol, and Association with Subjective Perceptions, in Social Drinkers. Alcohol Clin Exp Res. 2019 Mar;43(3):405-410. doi: 10.1111/acer.13962. Epub 2019 Feb 8.
- Derived from this study: PubMed 28774194Gowin JL, Sloan ME, Stangl BL, Vatsalya V, Ramchandani VA. Vulnerability for Alcohol Use Disorder and Rate of Alcohol Consumption. Am J Psychiatry. 2017 Nov 1;174(11):1094-1101. doi: 10.1176/appi.ajp.2017.16101180. Epub 2017 Aug 4.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vijay A Ramchandani, Ph.D. principal investigator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Alcohol in people with Alcoholic Intoxication, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BrAC Exposure (peak BrAC, Average BrAC) during self-administration (time frame: 2.5 hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00713492, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.