Alcohol Use DisorderPhase 1BED[IN]:36NCT03575403
Behavioral Effects of Drugs: Inpatient (36) (Alcohol, Duloxetine, and Methylphenidate)
A Phase 1 study testing Alcohol, Duloxetine (60 MG) and Methylphenidate in people with Alcohol Use Disorder, run by Craig Rush at 1 site in United States.
Trial summary
This study will evaluate the behavioral effects of alcohol during maintenance on placebo, duloxetine, methylphenidate and duloxetine combined with methylphenidate using sophisticated human laboratory methods. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Alcohol, Duloxetine (60 MG) and Methylphenidate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 15 Mar 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- able to speak/read English
- not seeking treatment at the time of the study
- one binge drinking episode (5+/4+ standard alcoholic drinks per drinking session for men and women, respectively) in the past 30 days
- recent alcohol use verified by ethyl glucuronide positive urine, as well as fulfillment of DSM-5 diagnostic criteria for alcohol use disorder
- ECG within normal limits
- otherwise healthy
Show all 10Show fewer
- body mass index of 19-35
- females using an effective form of birth control and not pregnant or breast feeding
- judged by the medical staff to be psychiatrically and physically healthy
- able to abstain from alcohol for 12 hours prior to session
Who cannot join
- Not under 21 years of age or over 55 years of age
- no contraindications/allergies to alcohol, duloxetine, or methylphenidate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Novel Drug Combination for Alcohol-Use Disorders: A Human Laboratory Study
This study will evaluate the behavioral effects of alcohol during maintenance on placebo, duloxetine, methylphenidate and duloxetine combined with methylphenidate using sophisticated human laboratory methods.
Read the detailed description
Prior to the outbreak of the COVID-19 virus and subsequent work-from-home orders from the state of Kentucky government, participants completed five overnight sessions at theUniversity of Kentucky Inpatient Research Unit in the medical center. The protocol was then changed to have five sessions scheduled to be completed on an outpatient basis in the late afternoon/early evening. This protocol change was enacted following the resumption of research in the fall of 2020.
For both the inpatient and outpatient portions of this protocol, the first of these sessions was a practice session to familiarize participants with experimental procedures. The subsequent four experimental sessions were conducted following one-week maintenance on a methylphenidate dose (0, 20, 40, and 60 mg/day; within-subjects factor) over the span of four weeks. Participants were assigned to either an active duloxetine arm (60 mg/day) or placebo arm (between-subjects factor) also for the span of four weeks. The outcome measures collected were the same for both the inpatient and outpatient aspects of the study.
Subjects received 30 mg of oral duloxetine one time daily. Note: only 2 subjects were enrolled in this arm prior to the arm being removed in the summer of 2020. Data from this arm will not be reported in order to avoid any HIPAA violation due to the small number of subjects in this arm.
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, visual inspection of their data revealed that their data was not appreciably different from participants in the 60 mg/day duloxetine arm. Therefore, we have added the data from these two participants to the 60 mg/day duloxetine arm for all reported data.
- Conditions
- Alcohol Use Disorder
- Being tested
- Alcohol, Placebos, Duloxetine (60 MG), Methylphenidate, Duloxetine (30 MG)
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlcoholDrug
In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
PlacebosDrug
Subjects will receive oral placebo capsules.
Duloxetine (60 MG)Drug
Subjects will receive 60-mg of oral duloxetine capsules.
MethylphenidateDrug
Subjects will receive methylphenidate capsules.
Duloxetine (30 MG)Drug
Subjects will receive 30-mg of oral duloxetine capsules.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Subjects received oral placebo capsules one time daily. Receives: Drug: Alcohol; Drug: Placebos; Drug: Methylphenidate |
| Duloxetine (60 MG) | Experimental | Subjects received 60 mg of oral duloxetine one time daily. Receives: Drug: Duloxetine (60 MG) |
| Duloxetine (30 MG) | Experimental | Subjects received 30 mg of oral duloxetine one time daily. Note: only 2 subjects were enrolled in this arm prior to the arm being removed in the summer of 2020. Data from this arm will not be reported in order to avoid any HIPAA violation due to the small number of subjects in this arm. Receives: Drug: Duloxetine (30 MG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reinforcing Effects (Pre-Alcohol Dose Consumption)
The reinforcing effects of alcohol will be determined using a alcohol purchase task procedure in which subjects will report the number of alcohol drinks they would purchase across changes in price. The questions that were asked were completely hypothetical. The reinforcing effects are measured during experimental session maintenance on methylphenidate and placebo or duloxetine. These data represent "alpha", which a rate measure of sensitivity to changes in price: greater values represent great sensitivity to price changes. These data were collected prior to consumption of the alcohol dose. There is no minimum or maximum value.
Measured: Measured at each methylphenidate dose-level over approximately four weeks of participation.
Reinforcing Effects (Post-Alcohol Dose Consumption)
The reinforcing effects of alcohol will be determined using a alcohol purchase procedure in which subjects will report the number of alcohol drinks they would purchase across changes in price. The questions that were asked were completely hypothetical. The reinforcing effects are measured during experimental session maintenance on methylphenidate and placebo or duloxetine. These data represent "alpha", which a rate measure of sensitivity to changes in price: greater values represent great sensitivity to price changes. These data were collected following consumption of the alcohol dose. There is no minimum or maximum value.
Measured: Measured at each methylphenidate dose-level over approximately four weeks of participation.
Secondary outcomes (8)
Visual Analog Scales of Alcohol Effects Following Methylphenidate (0 mg) Maintenance.
Subjects will complete measures using visual analog scales rated from 0-100 mm to report alcohol effects during four experimental sessions. These items will ask about alcohol effects. Higher scores indicate greater effects. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of oral alcohol
Measured: Measured at each methylphenidate dose-level over approximately four weeks of participation.
Visual Analog Scales of Alcohol Effects Following Methylphenidate (20 mg) Maintenance.
Subjects will complete measures using visual analog scales rated from 0-100 mm to report alcohol effects during four experimental sessions. These items will ask about alcohol effects. Higher scores indicate greater effects. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of oral alcohol
Measured: Measured at each methylphenidate dose-level over approximately four weeks of participation.
Visual Analog Scales of Alcohol Effects Following Methylphenidate (40 mg) Maintenance.
Subjects will complete measures using visual analog scales rated from 0-100 mm to report alcohol effects during four experimental sessions. These items will ask about alcohol effects. Higher scores indicate greater effects. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of oral alcohol
Measured: Measured at each methylphenidate dose-level over approximately four weeks of participation.
Visual Analog Scales of Alcohol Effects Following Methylphenidate (60 mg) Maintenance.
Subjects will complete measures using visual analog scales rated from 0-100 mm to report alcohol effects during four experimental sessions. These items will ask about alcohol effects. Higher scores indicate greater effects. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of oral alcohol
Measured: Measured at each methylphenidate dose-level over approximately four weeks of participation.
Breath Alcohol Level
Expired air samples for determining breath alcohol level (BAL) will be recorded during four experimental sessions. BALs were recorded as g/dl. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of oral alcohol. Greater values of BAL represent more alcohol absorbed following consumption.
Measured: Measured at each methylphenidate dose-level over approximately four weeks of participation.
Systolic Blood Pressure
Systolic blood pressure (millimeter of mercury) was recorded during four experimental sessions. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of oral alcohol.
Measured: Measured at each methylphenidate dose-level over approximately four weeks of participation.
Diastolic Blood Pressure
Diastolic blood pressure (millimeter of mercury) was recorded during four experimental sessions. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of oral alcohol.
Measured: Measured at each methylphenidate dose-level over approximately four weeks of participation.
Heart Rate
Heart rate (beats per minute) will be recorded during four experimental sessions. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of oral alcohol.
Measured: Measured at each methylphenidate dose-level over approximately four weeks of participation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start1 Sep 2018
- Primary completion15 Mar 2023
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol Use DisorderStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Craig Rush
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor-investigator, Craig Rush, University of Kentucky
- Investigators
- Craig Rush, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03575403
- Sponsor's protocol ID
- 44796
- Other IDs
- R01AA026255
- Acronym
- BED[IN]:36
- Status last verified
- May 2026
- First submitted
- 22 Jun 2018
- Last updated
- 9 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Drug Combination for Alcohol-Use Disorders: A Human Laboratory Study
- ClinicalTrials.gov ID
- NCT03575403
- Acronym / sponsor ID
- BED[IN]:36 / 44796
- Conditions
- Alcohol Use Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Craig RushUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 2 Jul 2018 (actual)
- Results
- Posted 10 Apr 2025
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 evaluate the behavioral effects of alcohol during maintenance on placebo, duloxetine, methylphenidate and duloxetine combined with methylphenidate using sophisticated human laboratory methods.
Detailed description
Prior to the outbreak of the COVID-19 virus and subsequent work-from-home orders from the state of Kentucky government, participants completed five overnight sessions at theUniversity of Kentucky Inpatient Research Unit in the medical center. The protocol was then changed to have five sessions scheduled to be completed on an outpatient basis in the late afternoon/early evening. This protocol change was enacted following the resumption of research in the fall of 2020.
For both the inpatient and outpatient portions of this protocol, the first of these sessions was a practice session to familiarize participants with experimental procedures. The subsequent four experimental sessions were conducted following one-week maintenance on a methylphenidate dose (0, 20, 40, and 60 mg/day; within-subjects factor) over the span of four weeks. Participants were assigned to either an active duloxetine arm (60 mg/day) or placebo arm (between-subjects factor) also for the span of four weeks. The outcome measures collected were the same for both the inpatient and outpatient aspects of the study.
Subjects received 30 mg of oral duloxetine one time daily. Note: only 2 subjects were enrolled in this arm prior to the arm being removed in the summer of 2020. Data from this arm will not be reported in order to avoid any HIPAA violation due to the small number of subjects in this arm.
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, visual inspection of their data revealed that their data was not appreciably different from participants in the 60 mg/day duloxetine arm. Therefore, we have added the data from these two participants to the 60 mg/day duloxetine arm for all reported data.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Alcohol, Drug: Placebos, Drug: MethylphenidateSubjects received oral placebo capsules one time daily. |
| Duloxetine (60 MG) | Experimental | Drug: Duloxetine (60 MG)Subjects received 60 mg of oral duloxetine one time daily. |
| Duloxetine (30 MG) | Experimental | Drug: Duloxetine (30 MG)Subjects received 30 mg of oral duloxetine one time daily. Note: only 2 subjects were enrolled in this arm prior to the arm being removed in the summer of 2020. Data from this arm will not be reported in order to avoid any HIPAA violation due to the small number of subjects in this arm. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- able to speak/read English
- not seeking treatment at the time of the study
- one binge drinking episode (5+/4+ standard alcoholic drinks per drinking session for men and women, respectively) in the past 30 days
- recent alcohol use verified by ethyl glucuronide positive urine, as well as fulfillment of DSM-5 diagnostic criteria for alcohol use disorder
- ECG within normal limits
Key exclusion criteria (2 listed)
- Not under 21 years of age or over 55 years of age
- no contraindications/allergies to alcohol, duloxetine, or methylphenidate
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 |
|---|---|---|
| AlcoholIn each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl. | Drug | Placebo |
| PlacebosSubjects will receive oral placebo capsules. | Drug | Placebo |
| Duloxetine (60 MG)Subjects will receive 60-mg of oral duloxetine capsules. | Drug | Duloxetine (60 MG) |
| MethylphenidateSubjects will receive methylphenidate capsules. | Drug | Placebo |
| Duloxetine (30 MG)Subjects will receive 30-mg of oral duloxetine capsules. | Drug | Duloxetine (30 MG) |
Primary outcome
Reinforcing Effects (Pre-Alcohol Dose Consumption)
Time frame: Measured at each methylphenidate dose-level over approximately four weeks of participation.
The reinforcing effects of alcohol will be determined using a alcohol purchase task procedure in which subjects will report the number of alcohol drinks they would purchase across changes in price. The questions that were asked were completely hypothetical. The reinforcing effects are measured during experimental session maintenance on methylphenidate and placebo or duloxetine. These data represent "alpha", which a rate measure of sensitivity to changes in price: greater values represent great sensitivity to price changes. These data were collected prior to consumption of the alcohol dose. There is no minimum or maximum value.
Reinforcing Effects (Post-Alcohol Dose Consumption)
Time frame: Measured at each methylphenidate dose-level over approximately four weeks of participation.
The reinforcing effects of alcohol will be determined using a alcohol purchase procedure in which subjects will report the number of alcohol drinks they would purchase across changes in price. The questions that were asked were completely hypothetical. The reinforcing effects are measured during experimental session maintenance on methylphenidate and placebo or duloxetine. These data represent "alpha", which a rate measure of sensitivity to changes in price: greater values represent great sensitivity to price changes. These data were collected following consumption of the alcohol dose. There is no minimum or maximum value.
8 secondary outcomes
Visual Analog Scales of Alcohol Effects Following Methylphenidate (0 mg) Maintenance.
Time frame: Measured at each methylphenidate dose-level over approximately four weeks of participation.
Visual Analog Scales of Alcohol Effects Following Methylphenidate (20 mg) Maintenance.
Time frame: Measured at each methylphenidate dose-level over approximately four weeks of participation.
Visual Analog Scales of Alcohol Effects Following Methylphenidate (40 mg) Maintenance.
Time frame: Measured at each methylphenidate dose-level over approximately four weeks of participation.
Visual Analog Scales of Alcohol Effects Following Methylphenidate (60 mg) Maintenance.
Time frame: Measured at each methylphenidate dose-level over approximately four weeks of participation.
Breath Alcohol Level
Time frame: Measured at each methylphenidate dose-level over approximately four weeks of participation.
Systolic Blood Pressure
Time frame: Measured at each methylphenidate dose-level over approximately four weeks of participation.
Diastolic Blood Pressure
Time frame: Measured at each methylphenidate dose-level over approximately four weeks of participation.
Heart Rate
Time frame: Measured at each methylphenidate dose-level over approximately four weeks of participation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Craig Rush, PhD principal investigator
University of Kentucky
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, Duloxetine (60 MG) and Methylphenidate in people with Alcohol Use Disorder, run by Craig Rush 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 10 inclusion and 2 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 9 Jun 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 10 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Reinforcing Effects (Pre-Alcohol Dose Consumption) (time frame: Measured at each methylphenidate dose-level over approximately four weeks of participation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2026.