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
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