Clinical trial NCT03575403: Behavioral Effects of Drugs: Inpatient (36) (Alcohol, Duloxetine, and Methylphenidate)
Official title: A Novel Drug Combination for Alcohol-Use Disorders: A Human Laboratory Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alcohol Use Disorder
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2018-07-02
Enrollment: 19
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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
* 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

Exclusion Criteria

* Not under 21 years of age or over 55 years of age
* no contraindications/allergies to alcohol, duloxetine, or methylphenidate

Primary outcomes:
measure: Reinforcing Effects (Pre-Alcohol Dose Consumption)
timeFrame: Measured at each methylphenidate dose-level over approximately four weeks of participation.
measure: Reinforcing Effects (Post-Alcohol Dose Consumption)
timeFrame: Measured at each methylphenidate dose-level over approximately four weeks of participation.
Secondary outcomes:
measure: Visual Analog Scales of Alcohol Effects Following Methylphenidate (0 mg) Maintenance.
timeFrame: Measured at each methylphenidate dose-level over approximately four weeks of participation.
measure: Visual Analog Scales of Alcohol Effects Following Methylphenidate (20 mg) Maintenance.
timeFrame: Measured at each methylphenidate dose-level over approximately four weeks of participation.
measure: Visual Analog Scales of Alcohol Effects Following Methylphenidate (40 mg) Maintenance.
timeFrame: Measured at each methylphenidate dose-level over approximately four weeks of participation.
measure: Visual Analog Scales of Alcohol Effects Following Methylphenidate (60 mg) Maintenance.
timeFrame: Measured at each methylphenidate dose-level over approximately four weeks of participation.
measure: Breath Alcohol Level
timeFrame: Measured at each methylphenidate dose-level over approximately four weeks of participation.
measure: Systolic Blood Pressure
timeFrame: Measured at each methylphenidate dose-level over approximately four weeks of participation.
measure: Diastolic Blood Pressure
timeFrame: Measured at each methylphenidate dose-level over approximately four weeks of participation.
measure: Heart Rate
timeFrame: Measured at each methylphenidate dose-level over approximately four weeks of participation.
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Craig Rush, PhD
role: PRINCIPAL_INVESTIGATOR
References: