Cocaine Use Disorder
Conditions
Brief summary
This study will determine the influence of methylphenidate (e.g., Ritalin®) and duloxetine (Cymbalta®), alone and in combination, on the cocaine use as measured by self-report and urine drug screens.
Interventions
DRUGDuloxetine
The pharmacodynamic effects of duloxetine will be determined during maintenance on placebo and methylphenidate
DRUGMethylphenidate
The pharmacodynamic effects of methylphenidate maintenance will be determined during maintenance on placebo and duloxetine.
DRUGPlacebo
The pharmacodynamic effects of placebo will be determined during maintenance on placebo and duloxetine.
Sponsors
National Institute on Drug Abuse (NIDA)
University of Kentucky
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Recent cocaine use * Seeking treatment for 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 or current unstable physical disease (e.g., past myocardial infarction, uncontrolled hypertension, diabetes, head trauma, seizures or CNS tumors) or current or past histories of serious psychiatric disorder or suicidal risk, other than substance abuse or dependence, will be excluded from research participation * Females not currently using effective birth control * Contraindications to cocaine, methylphenidate or duloxetine * Currently using opioids for pain or who are currently maintained on methadone or buprenorphine for opioid use disorder will be excluded from participation * Body weight less than 50 kg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Cocaine Positive Urines | Six weeks | Cocaine use will be assessed using qualitative urine drug screens over a six week period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-Reported Cocaine Use | Six weeks | Cocaine use will be assessed using self-report on the Time Line Follow Back over a six week period. |
| Blood Pressure | Six weeks | Blood Pressure in mmHG will be measured on each week day over a six week period. |
| Heart Rate | Six weeks | Heart Rate in beats per minute will be measured on each week day over a six week period. |
| Side effects | Six weeks | Subjects will complete a side effects questionnaire on each week day over a six week period. Side Effects questions will query subjects about common effects of centrally active medications. |
Countries
United States
Outcome results
None listed