Cocaine Use Disorder
Conditions
Brief 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.
Interventions
DRUGCocaine
The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and duloxetine.
DRUGPlacebo oral capsule
The pharmacodynamic effects of placebo will be determined during maintenance on placebo and duloxetine.
DRUGMethylphenidate
The pharmacodynamic effects of methylphenidate maintenance will be determined during maintenance on placebo and duloxetine.
Sponsors
National Institute on Drug Abuse (NIDA)
Craig Rush
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reinforcing Effects of Cocaine Following Placebo Maintenance. | 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. |
| Reinforcing Effects of Cocaine Following Duloxetine Maintenance. | 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. |
| Reinforcing Effects of Cocaine Following Methylphenidate Maintenance. | 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. |
| Reinforcing Effects of Cocaine Following Methylphenidate and Duloxetine Maintenance. | 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
| Measure | Time frame | Description |
|---|---|---|
| Drug Effect Questionnaire | 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. |
| Heart rate | Daily over approximately four week inpatient admissions. | Beats per minute. Measured daily during inpatient admission. |
| Blood pressure | Daily over approximately four week inpatient admissions. | mmHg.Measured daily during inpatient admission. |
| Delay Discounting Task | 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). |
| Side effects | 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. |
| Inhibitory Control | 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. |
| Temperature | Daily over approximately four week inpatient admissions. | Degrees fahrenheit. Measured daily during inpatient admission. |
| Adjective Rating Scale-Sedative | 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. |
| Attentional Bias | 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. |
| Adjective Rating Scale-Stimulant | 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. |
Countries
United States
Outcome results
None listed