Methylphenidate-Duloxetine Combinations for Cocaine Dependence

Study Overview
=================
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.

Official Title
-----------------
Randomized Clinical Trial: 03 (Methylphenidate and Duloxetine)

Conditions
-----------------
Cocaine Use Disorder

Intervention / Treatment
-----------------
* Drug: Methylphenidate
* Drug: Placebo
* Drug: Duloxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. | Drug: Methylphenidate<br>* The pharmacodynamic effects of methylphenidate maintenance will be determined during maintenance on placebo and duloxetine.<br>* Other names: Ritalin;Drug: Placebo<br>* The pharmacodynamic effects of placebo will be determined during maintenance on placebo and duloxetine.<br>|
| Experimental: Duloxetine<br>Subjects will be maintained on oral duloxetine. Subjects will be maintained on placebo and methylphenidate during duloxetine maintenance. | Drug: Methylphenidate<br>* The pharmacodynamic effects of methylphenidate maintenance will be determined during maintenance on placebo and duloxetine.<br>* Other names: Ritalin;Drug: Placebo<br>* The pharmacodynamic effects of placebo will be determined during maintenance on placebo and duloxetine.<br>Drug: Duloxetine<br>* The pharmacodynamic effects of duloxetine will be determined during maintenance on placebo and methylphenidate<br>* Other names: Cymbalta;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Cocaine Positive Urines | Cocaine use will be assessed using qualitative urine drug screens over a six week period. | Six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Reported Cocaine Use | Cocaine use will be assessed using self-report on the Time Line Follow Back over a six week period. | Six weeks | 
| Blood Pressure | Blood Pressure in mmHG will be measured on each week day over a six week period. | Six weeks | 
| Heart Rate | Heart Rate in beats per minute will be measured on each week day over a six week period. | Six weeks | 
| Side effects | 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. | Six weeks |