Methylphenidate-Duloxetine Combinations for Cocaine Dependence

Cocaine Use Disorder Clinical Trial

Official title:

Randomized Clinical Trial: 03 (Methylphenidate and Duloxetine)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02700711
• Other study ID #: RCT: 03
• Secondary ID: R56DA041201
• Status: Completed
• Phase: Phase 1
• Start date: February 2016
• Est. completion date: June 2018

Study information

• Verified date: June 2018
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cocaine Use Disorder

Intervention

Drug:
• Methylphenidate
The pharmacodynamic effects of methylphenidate maintenance will be determined during maintenance on placebo and duloxetine.
• Placebo
The pharmacodynamic effects of placebo will be determined during maintenance on placebo and duloxetine.
• Duloxetine
The pharmacodynamic effects of duloxetine will be determined during maintenance on placebo and methylphenidate

Locations

Country	Name	City	State
United States	University of Kentucky Medical Center	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
University of Kentucky	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Cocaine Positive Urines	Cocaine use will be assessed using qualitative urine drug screens over a six week period.	Six weeks
Secondary	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
Secondary	Blood Pressure	Blood Pressure in mmHG will be measured on each week day over a six week period.	Six weeks
Secondary	Heart Rate	Heart Rate in beats per minute will be measured on each week day over a six week period.	Six weeks
Secondary	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