Clinical trial NCT03519022: Behavioral Effects of Drugs: Inpatient (35)
Official title: Influence of Methylphenidate and Duloxetine Maintenance on Pharmacodynamic Effects of Cocaine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cocaine Use Disorder
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2018-05-08
Enrollment: 9
Sex: ALL
Minimum age (years): 18
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 determine the influence of methylphenidate (Metadate®) and duloxetine (Cymbalta®), alone and in combination, on the reinforcing, subjective and physiological effects of cocaine.


Eligibility criteria: Inclusion Criteria:

* Recent cocaine use

Exclusion Criteria:

* Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant
* Current or past histories of substance abuse or dependence that are deemed by the study physicians to interfere with study completion
* History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation
* Females not currently using effective birth control
* Contraindications to cocaine, methylphenidate or duloxetine

Primary outcomes:
measure: Reinforcing Effects of Cocaine Following Placebo Maintenance.
timeFrame: Following at least 4 days of maintenance on placebo during inpatient admission.
measure: Reinforcing Effects of Cocaine Following Duloxetine Maintenance.
timeFrame: Following at least 4 days of maintenance on duloxetine during inpatient admission.
measure: Reinforcing Effects of Cocaine Following Methylphenidate Maintenance.
timeFrame: Following at least 4 days of maintenance on duloxetine during inpatient admission.
measure: Reinforcing Effects of Cocaine Following Methylphenidate and Duloxetine Maintenance.
timeFrame: Following at least 4 days of maintenance on methylphenidate and duloxetine during inpatient admission.
Secondary outcomes:
measure: Adjective Rating Scale-Sedative
timeFrame: Nine times over approximately four weeks inpatient admission.
measure: Adjective Rating Scale-Stimulant
timeFrame: Nine times over approximately four weeks inpatient admission.
measure: Drug Effect Questionnaire
timeFrame: Nine times over approximately four weeks inpatient admission.
measure: Heart rate
timeFrame: Daily over approximately four week inpatient admissions.
measure: Blood pressure
timeFrame: Daily over approximately four week inpatient admissions.
measure: Temperature
timeFrame: Daily over approximately four week inpatient admissions.
measure: Side effects
timeFrame: Daily over approximately four week inpatient admissions.
measure: Delay Discounting Task
timeFrame: Nine times over approximately four weeks inpatient admission.
measure: Attentional Bias
timeFrame: Nine times over approximately four weeks inpatient admission.
measure: Inhibitory Control
timeFrame: Nine times over approximately four weeks inpatient admission.
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Craig R Rush, PhD
role: PRINCIPAL_INVESTIGATOR
References: