Skip to main content
OpenTrials
Completed

NCT Number: NCT03519022

Behavioral Effects of Drugs: Inpatient (35)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cocaine Use Disorder

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Kentucky Medical Center

Lexington, Kentucky, 40536-0086, 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

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

Treatment and study plan

Cocaine

Drug

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

Placebo oral capsule

Drug

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

Methylphenidate

Drug

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

Other names: Metadate®

Primary outcomes

  1. Reinforcing Effects of Cocaine Following Placebo Maintenance.

    Time frame: Following at least 4 days of maintenance on placebo during inpatient admission.

    Number of cocaine doses earned by subjects on a progressive ratio schedule of reinforcement.

  2. Reinforcing Effects of Cocaine Following Duloxetine Maintenance.

    Time frame: Following at least 4 days of maintenance on duloxetine during inpatient admission.

    Number of cocaine doses earned by subjects on a progressive ratio schedule of reinforcement.

  3. Reinforcing Effects of Cocaine Following Methylphenidate Maintenance.

    Time frame: Following at least 4 days of maintenance on duloxetine during inpatient admission.

    Number of cocaine doses earned by subjects on a progressive ratio schedule of reinforcement.

  4. Reinforcing Effects of Cocaine Following Methylphenidate and Duloxetine Maintenance.

    Time frame: Following at least 4 days of maintenance on methylphenidate and duloxetine during inpatient admission.

    Number of cocaine doses earned by subjects on a progressive ratio schedule of reinforcement.

Secondary outcomes

  1. Adjective Rating Scale-Sedative

    Time frame: Nine times over approximately four weeks inpatient admission.

    Subjects will complete the adjective rating scale during nine sessions while they are admitted to our inpatient unit. Responses to 16 items are summed (total score=0-64; Higher values=more sedation) to calculate scores on a sedative subscale.

  2. Adjective Rating Scale-Stimulant

    Time frame: Nine times over approximately four weeks inpatient admission.

    Subjects will complete the adjective rating scale during nine sessions while they are admitted to our inpatient unit. Responses to 16 items are summed (total score=0-64; Higher values=more stimulation) to calculate total scores on a stimulant subscale.

  3. Drug Effect Questionnaire

    Time frame: Nine times over approximately four weeks inpatient admission.

    Subjects will complete the drug effect questionnaire during nine sessions while they are admitted to our inpatient unit. The items (total scores=0-100; Higher scores=greater drug effect) on this scale categorize the constellation of drug effects endorsed by subjects.

  4. Heart rate

    Time frame: Daily over approximately four week inpatient admissions.

    Beats per minute. Measured daily during inpatient admission.

  5. Blood pressure

    Time frame: Daily over approximately four week inpatient admissions.

    mmHg.Measured daily during inpatient admission.

  6. Temperature

    Time frame: Daily over approximately four week inpatient admissions.

    Degrees fahrenheit. Measured daily during inpatient admission.

  7. Side effects

    Time frame: Daily over approximately four week inpatient admissions.

    Subjects will complete a side effects questionnaire daily while they reside on the inpatient unit. Side Effects questions will query subjects about common effects of centrally active medications.

  8. Delay Discounting Task

    Time frame: Nine times over approximately four weeks inpatient admission.

    Subjects will complete the delay discounting task during nine sessions while they are admitted to our inpatient unit. Responses will be used to calculate discounting slope (i.e., K).

  9. Attentional Bias

    Time frame: Nine times over approximately four weeks inpatient admission.

    Subjects will complete attentional bias during nine sessions while they are admitted to our inpatient unit. Time attending to drug stimuli will be used to evaluate attentional bias.

  10. Inhibitory Control

    Time frame: Nine times over approximately four weeks inpatient admission.

    Subjects will complete an inhibitory control task during nine sessions while they are admitted to our inpatient unit. Ability to inhibit prepotent responding will be used to calculate inhibitory control.

Sponsors and collaborators

Lead sponsor

Craig Rush

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Influence of Methylphenidate and Duloxetine Maintenance on Pharmacodynamic Effects of Cocaine

Acronym: BED IN 35

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 8, 2018
Registry last updated
Jun 25, 2019

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.