Behavioral Effects of Drugs: Inpatient (35)

Cocaine Use Disorder Clinical Trial

— BED IN 35  

Official title:

Influence of Methylphenidate and Duloxetine Maintenance on Pharmacodynamic Effects of Cocaine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03519022
• Other study ID #: 43500
• Status: Completed
• Phase: Early Phase 1
• Start date: June 1, 2018
• Est. completion date: May 31, 2019

Study information

• Verified date: July 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 (Metadate®) and duloxetine (Cymbalta®), alone and in combination, on the reinforcing, subjective and physiological effects of cocaine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Cocaine Use Disorder

Intervention

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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Craig Rush	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reinforcing Effects of Cocaine Following Placebo Maintenance.	Number of cocaine doses earned by subjects on a progressive ratio schedule of reinforcement.	Following at least 4 days of maintenance on placebo during inpatient admission.
Primary	Reinforcing Effects of Cocaine Following Duloxetine Maintenance.	Number of cocaine doses earned by subjects on a progressive ratio schedule of reinforcement.	Following at least 4 days of maintenance on duloxetine during inpatient admission.
Primary	Reinforcing Effects of Cocaine Following Methylphenidate Maintenance.	Number of cocaine doses earned by subjects on a progressive ratio schedule of reinforcement.	Following at least 4 days of maintenance on duloxetine during inpatient admission.
Primary	Reinforcing Effects of Cocaine Following Methylphenidate and Duloxetine Maintenance.	Number of cocaine doses earned by subjects on a progressive ratio schedule of reinforcement.	Following at least 4 days of maintenance on methylphenidate and duloxetine during inpatient admission.
Secondary	Adjective Rating Scale-Sedative	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.	Nine times over approximately four weeks inpatient admission.
Secondary	Adjective Rating Scale-Stimulant	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.	Nine times over approximately four weeks inpatient admission.
Secondary	Drug Effect Questionnaire	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.	Nine times over approximately four weeks inpatient admission.
Secondary	Heart rate	Beats per minute. Measured daily during inpatient admission.	Daily over approximately four week inpatient admissions.
Secondary	Blood pressure	mmHg.Measured daily during inpatient admission.	Daily over approximately four week inpatient admissions.
Secondary	Temperature	Degrees fahrenheit. Measured daily during inpatient admission.	Daily over approximately four week inpatient admissions.
Secondary	Side effects	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.	Daily over approximately four week inpatient admissions.
Secondary	Delay Discounting Task	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).	Nine times over approximately four weeks inpatient admission.
Secondary	Attentional Bias	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.	Nine times over approximately four weeks inpatient admission.
Secondary	Inhibitory Control	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.	Nine times over approximately four weeks inpatient admission.