A Novel Drug Combination as a Pharmacotherapeutic for Methamphetamine-Use Disorder
Overview
- Phase
- Phase 1
- Intervention
- Methamphetamine
- Conditions
- Methamphetamine Use Disorder
- Sponsor
- Craig Rush
- Enrollment
- 8
- Locations
- 2
- Primary Endpoint
- Reinforcing Effects of Methamphetamine Following Methylphenidate (0 mg; Placebo) Maintenance.
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This study will evaluate the behavioral effects of methamphetamine during maintenance on placebo, duloxetine, methylphenidate and duloxetine combined with methylphenidate using sophisticated human laboratory methods.
Investigators
Craig Rush
Professor
University of Kentucky
Eligibility Criteria
Inclusion Criteria
- •recent use of inhaled (i.e., snorted), smoked or injected methamphetamine
Exclusion Criteria
- •Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant.
- •Current or past histories of substance use 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 methamphetamine, methylphenidate, or duloxetine.
Arms & Interventions
Placebo Comparator: Placebo
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Intervention: Methamphetamine
Placebo Comparator: Placebo
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Intervention: Methylphenidate
Placebo Comparator: Placebo
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Intervention: Placebo oral capsule
Active Comparator: Duloxetine
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Intervention: Methamphetamine
Active Comparator: Duloxetine
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Intervention: Methylphenidate
Active Comparator: Duloxetine
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Intervention: Placebo oral capsule
Active Comparator: Duloxetine
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Intervention: Duloxetine
Outcomes
Primary Outcomes
Reinforcing Effects of Methamphetamine Following Methylphenidate (0 mg; Placebo) Maintenance.
Time Frame: Following at least 4 days of maintenance on placebo during inpatient admission, up to 1 week
Number of methamphetamine doses earned by subjects on a progressive ratio schedule of reinforcement. Subjects sample a dose of methamphetamine (0, 10, or 20 mg) and then have ten opportunities (e.g., trials) to "work" for a 1/10th of the sampled dose via clicking on a computer mouse (i.e., 10 completed trials is the full sampled dose).
Reinforcing Effects of Methamphetamine Following Methylphenidate (60 mg) Maintenance.
Time Frame: Following at least 4 days of maintenance on drug during inpatient admission, up to 1 week
Number of methamphetamine doses earned by subjects on a progressive ratio schedule of reinforcement. Subjects sample a dose of methamphetamine (0, 10, or 20 mg) and then have the ten opportunities (e.g., trials) to "work" for a 1/10th of the sampled dose via clicking on a computer mouse (i.e., 10 completed trials is the full sampled dose).
Reinforcing Effects of Methamphetamine Following Methylphenidate (20 mg) Maintenance.
Time Frame: Following at least 4 days of maintenance on drug during inpatient admission, up to 1 week
Number of methamphetamine doses earned by subjects on a progressive ratio schedule of reinforcement. Subjects sample a dose of methamphetamine (0, 10, or 20 mg) and then have the ten opportunities (e.g., trials) to "work" for a 1/10th of the sampled dose via clicking on a computer mouse (i.e., 10 completed trials is the full sampled dose).
Reinforcing Effects of Methamphetamine Following Methylphenidate (40 mg) Maintenance.
Time Frame: Following at least 4 days of maintenance on drug during inpatient admission, up to 1 week
Number of methamphetamine doses earned by subjects on a progressive ratio schedule of reinforcement. Subjects sample a dose of methamphetamine (0, 10, or 20 mg) and then have the ten opportunities (e.g., trials) to "work" for a 1/10th of the sampled dose via clicking on a computer mouse (i.e., 10 completed trials is the full sampled dose).
Secondary Outcomes
- Heart Rate After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Heart Rate After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Heart Rate After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Heart Rate After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Temperature After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Temperature After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Temperature After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (0 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (60 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Temperature After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (20 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (0 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (0 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (20 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (40 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (60 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (20 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (40 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (40 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (60 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)