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Completed

NCT Number: NCT02700711

Methylphenidate-Duloxetine Combinations for Cocaine Dependence

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.

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Key information

Conditions

Cocaine Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methylphenidate

Drug

The pharmacodynamic effects of methylphenidate maintenance will be determined during maintenance on placebo and duloxetine.

Other names: Ritalin

Placebo

Drug

The pharmacodynamic effects of placebo will be determined during maintenance on placebo and duloxetine.

Duloxetine

Drug

The pharmacodynamic effects of duloxetine will be determined during maintenance on placebo and methylphenidate

Other names: Cymbalta

Primary outcomes

  1. Number of Cocaine Positive Urines

    Time frame: Six weeks

    Cocaine use will be assessed using qualitative urine drug screens over a six week period.

Secondary outcomes

  1. Self-Reported Cocaine Use

    Time frame: Six weeks

    Cocaine use will be assessed using self-report on the Time Line Follow Back over a six week period.

  2. Blood Pressure

    Time frame: Six weeks

    Blood Pressure in mmHG will be measured on each week day over a six week period.

  3. Heart Rate

    Time frame: Six weeks

    Heart Rate in beats per minute will be measured on each week day over a six week period.

  4. Side effects

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Kentucky

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Randomized Clinical Trial: 03 (Methylphenidate and Duloxetine)

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 7, 2016
Registry last updated
Jun 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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