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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance. |
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| Duloxetine | Active Comparator | Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Cocaine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cocaine | Drug | The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and duloxetine. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Craig R Rush, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky Medical Center | Lexington | Kentucky | 40536-0086 | United States |
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| ID | Term |
|---|---|
| D003042 | Cocaine |
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
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| Placebo oral capsule | Drug | The pharmacodynamic effects of placebo will be determined during maintenance on placebo and duloxetine. |
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| Methylphenidate | Drug | The pharmacodynamic effects of methylphenidate maintenance will be determined during maintenance on placebo and duloxetine. |
|
|
| 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. |
| 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. |
| Heart rate | Beats per minute. Measured daily during inpatient admission. | Daily over approximately four week inpatient admissions. |
| Blood pressure | mmHg.Measured daily during inpatient admission. | Daily over approximately four week inpatient admissions. |
| Temperature | Degrees fahrenheit. Measured daily during inpatient admission. | Daily over approximately four week inpatient admissions. |
| 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. |
| 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. |
| 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. |
| 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. |
| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |