An Early Phase 1 interventional study of Cocaine and Placebo oral capsule in Cocaine Use Disorder, sponsored by Craig Rush. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-25.
Sponsored by Craig Rush · Early Phase 1, Interventional, and Basic science
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.
Craig Rush is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Cocaine · Drug: Placebo oral capsule · Drug: Methylphenidate
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.
Drug: Cocaine · Drug: Placebo oral capsule · Drug: Methylphenidate
The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and duloxetine.
The pharmacodynamic effects of placebo will be determined during maintenance on placebo and duloxetine.
The pharmacodynamic effects of methylphenidate maintenance will be determined during maintenance on placebo and duloxetine.
Also known as: Metadate®
Reinforcing Effects of Cocaine Following Placebo Maintenance.
Number of cocaine doses earned by subjects on a progressive ratio schedule of reinforcement.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Following at least 4 days of maintenance on methylphenidate and duloxetine during inpatient admission.
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.
Time frame: Nine times over approximately four weeks inpatient admission.
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.
Time frame: 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.
Time frame: Nine times over approximately four weeks inpatient admission.
Heart rate
Beats per minute. Measured daily during inpatient admission.
Time frame: Daily over approximately four week inpatient admissions.
Blood pressure
mmHg.Measured daily during inpatient admission.
Time frame: Daily over approximately four week inpatient admissions.
Temperature
Degrees fahrenheit. Measured daily during inpatient admission.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Nine times over approximately four weeks inpatient admission.
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2018 to primary completion in May 2019, 11 months.
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This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Cocaine · Methylphenidate
Craig Rush