Phase 1
N=8
Behavioral Effects of Drugs (Inpatient): 40 [Methamphetamine, Methylphenidate, Duloxetine]
Methamphetamine Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04178993 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcome: Primary: Reinforcing Effects of Methamphetamine Following Methylphenidate (0 mg; Placebo) Maintenance. — 0; 0; 3.33; 7.25 Trials Completed
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Methamphetamine (Drug); Methylphenidate (Drug); Placebo oral capsule (Drug); Duloxetine (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Craig Rush
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reinforcing Effects of Methamphetamine Following Methylphenidate (0 mg; Placebo) Maintenance. |
0; 0; 3.33; 7.25; 10; 9.75 | — |
| PRIMARY Reinforcing Effects of Methamphetamine Following Methylphenidate (20 mg) Maintenance. |
0; 2.50; 6.67; 7.00; 8.00; 9.75 | — |
| PRIMARY Reinforcing Effects of Methamphetamine Following Methylphenidate (40 mg) Maintenance. |
1.67; 0; 10; 5.00; 10; 10 | — |
| PRIMARY Reinforcing Effects of Methamphetamine Following Methylphenidate (60 mg) Maintenance. |
2.33; 0; 3.33; 7.50; 10; 9.75 | — |
| SECONDARY Heart Rate After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance. |
77.67; 78.00; 87.33; 77.25; 81.33; 83.75 | — |
| SECONDARY Heart Rate After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance. |
83.67; 76.00; 84.33; 78.50; 85.67; 89.50 | — |
| SECONDARY Heart Rate After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance. |
85.00; 91.25; 89.67; 87.75; 87.67; 87.00 | — |
| SECONDARY Heart Rate After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance. |
87.33; 88.00; 83.67; 87.50; 99.67; 88.00 | — |
| SECONDARY Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance. |
132.67; 128.75; 133.00; 131.00; 132.67; 144.25 | — |
| SECONDARY Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance. |
129.67; 124.25; 131.67; 128.00; 130.33; 132.75 | — |
| SECONDARY Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance. |
133.33; 129.75; 129.00; 132.25; 130.00; 139.25 | — |
| SECONDARY Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance. |
139.00; 127.00; 138.67; 129.75; 139.67; 135.25 | — |
| SECONDARY Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance. |
80.00; 78.50; 82.33; 83.75; 87.33; 86.25 | — |
| SECONDARY Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance. |
81.67; 74.50; 85.33; 83.25; 83.00; 85.00 | — |
| SECONDARY Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance. |
78.00; 81.00; 84.67; 82.25; 84.67; 85.00 | — |
| SECONDARY Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance. |
82.67; 82.25; 81.67; 82.25; 88.33; 84.25 | — |
| SECONDARY Temperature After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance. |
98.10; 98.45; 98.23; 98.48; 98.40; 98.48 | — |
| SECONDARY Temperature After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance. |
98.37; 98.50; 98.10; 98.75; 98.27; 98.35 | — |
| SECONDARY Temperature After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance. |
98.17; 98.60; 98.13; 98.65; 98.43; 98.55 | — |
| SECONDARY Temperature After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance. |
98.37; 98.65; 98.43; 98.65; 98.47; 98.58 | — |
| SECONDARY Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (0 mg) Maintenance. |
1.33; 0.00; 1.00; 0.00; 1.00; 0.00 | — |
| SECONDARY Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (0 mg) Maintenance. |
22.33; 0.00; 1.00; 1.00; 0.67; 0.00 | — |
| SECONDARY Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (0 mg) Maintenance. |
10.33; 0.00; 0.67; 0.50; 0.67; 0.00 | — |
| SECONDARY Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (20 mg) Maintenance. |
3.00; 0.00; 1.33; 1.00; 1.67; 0.00 | — |
| SECONDARY Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (20 mg) Maintenance. |
10.67; 0.50; 2.00; 0.50; 2.00; 0.00 | — |
| SECONDARY Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (20 mg) Maintenance. |
4.33; 0.00; 9.33; 1.00; 3.33; 0.00 | — |
| SECONDARY Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (40 mg) Maintenance. |
0.00; 0.00; 0.00; 0.50; 0.00; 0.00 | — |
| SECONDARY Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (40 mg) Maintenance. |
8.67; 5.50; 5.33; 1.00; 3.00; 0.00 | — |
| SECONDARY Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (40 mg) Maintenance. |
1.33; 0.00; 0.33; 1.25; 0.00; 0.00 | — |
| SECONDARY Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (60 mg) Maintenance. |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (60 mg) Maintenance. |
0.00; 0.00; 5.00; 1.00; 0.00; 0.00 | — |
| SECONDARY Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (60 mg) Maintenance. |
6.67; 0.00; 0.00; 1.25; 0.33; 0.00 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04178993). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.