Methamphetamine Use DisorderPhase 1NCT04178993
Behavioral Effects of Drugs (Inpatient): 40 [Methamphetamine, Methylphenidate, Duloxetine]
A Phase 1 study testing Methamphetamine, Methylphenidate and Duloxetine in people with Methamphetamine Use Disorder, run by Craig Rush at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Methamphetamine Use Disorder
- What is being tested?
- Methamphetamine, Methylphenidate and Duloxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2019to 5 May 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- recent use of inhaled (i.e., snorted), smoked or injected methamphetamine
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Kentucky
Lexington, Kentucky, 40507
University of Kentucky Medical Center
Lexington, Kentucky, 40536
About this study
Official title: A Novel Drug Combination as a Pharmacotherapeutic for Methamphetamine-Use Disorder
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.
- Conditions
- Methamphetamine Use Disorder
- Being tested
- Methamphetamine, Methylphenidate, Placebo oral capsule, Duloxetine
- Keywords
- Methamphetamine, Methylphenidate, Duloxetine Hydrochloride, Central Nervous System Stimulants, Physiological Effects of Drugs, Dopamine Uptake Inhibitors, Serotonin and Noradrenaline Reuptake Inhibitors, Membrane Transport Modulators, Neurotransmitter Agents, Dopamine Agents, Molecular Mechanisms of Pharmacological Action, Sensory System Agents, Peripheral Nervous System Agents, Vasoconstrictor Agents, Antidepressive Agents, Psychotropic Drugs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethamphetamineDrug
Also called Metamfetamine
In each arm, subjects will receive doses of methamphetamine.
MethylphenidateDrug
Also called Metadate®
In each arm, subjects will receive methylphenidate capsules.
Placebo oral capsuleDrug
Also called Lactose
In each arm, subjects will receive placebo capsules.
DuloxetineDrug
Also called Cymbalta®
Subjects will receive duloxetine capsules in the duloxetine arm.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Comparator: Placebo | Placebo comparator | 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. Receives: Drug: Methamphetamine; Drug: Methylphenidate; Drug: Placebo oral capsule |
| Active Comparator: Duloxetine | Active comparator | 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. Receives: Drug: Methamphetamine; Drug: Methylphenidate; Drug: Placebo oral capsule; Drug: Duloxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reinforcing Effects of Methamphetamine Following Methylphenidate (0 mg; Placebo) Maintenance.
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).
Measured: Following at least 4 days of maintenance on placebo during inpatient admission, up to 1 week
Reinforcing Effects of Methamphetamine Following Methylphenidate (20 mg) Maintenance.
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).
Measured: Following at least 4 days of maintenance on drug during inpatient admission, up to 1 week
Reinforcing Effects of Methamphetamine Following Methylphenidate (40 mg) Maintenance.
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).
Measured: Following at least 4 days of maintenance on drug during inpatient admission, up to 1 week
Reinforcing Effects of Methamphetamine Following Methylphenidate (60 mg) Maintenance.
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).
Measured: Following at least 4 days of maintenance on drug during inpatient admission, up to 1 week
Secondary outcomes (28)
Heart Rate After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.
Heart Rate (beats per minute) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Measured: Daily over approximately 1 week of inpatient stay.
Heart Rate After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.
Heart Rate (beats per minute) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Measured: Daily over approximately 1 week of inpatient stay.
Heart Rate After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.
Heart Rate (beats per minute) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Measured: Daily over approximately 1 week of inpatient stay.
Heart Rate After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.
Heart Rate (beats per minute) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Measured: Daily over approximately 1 week of inpatient stay.
Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.
Systolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Measured: Daily over approximately 1 week of inpatient stay.
Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.
Systolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Measured: Daily over approximately 1 week of inpatient stay.
Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.
Systolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Measured: Daily over approximately 1 week of inpatient stay.
Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.
Systolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Measured: Daily over approximately 1 week of inpatient stay.
Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.
Diastolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Measured: Daily over approximately 1 week of inpatient stay.
Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.
Diastolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Measured: Daily over approximately 1 week of inpatient stay.
Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.
Diastolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Measured: Daily over approximately 1 week of inpatient stay.
Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.
Diastolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Measured: Daily over approximately 1 week of inpatient stay.
Temperature After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.
Oral temperature (degrees fahrenheit) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Measured: Daily over approximately 1 week of inpatient stay.
Temperature After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.
Oral temperature (degrees fahrenheit) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Measured: Daily over approximately 1 week of inpatient stay.
Temperature After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.
Oral temperature (degrees fahrenheit) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Measured: Daily over approximately 1 week of inpatient stay.
Temperature After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.
Oral temperature (degrees fahrenheit) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Measured: Daily over approximately 1 week of inpatient stay.
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.
Measured: Daily over approximately 1 week of inpatient stay.
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.
Measured: Daily over approximately 1 week of inpatient stay.
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.
Measured: Daily over approximately 1 week of inpatient stay.
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.
Measured: Daily over approximately 1 week of inpatient stay.
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.
Measured: Daily over approximately 1 week of inpatient stay.
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.
Measured: Daily over approximately 1 week of inpatient stay.
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.
Measured: Daily over approximately 1 week of inpatient stay.
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.
Measured: Daily over approximately 1 week of inpatient stay.
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.
Measured: Daily over approximately 1 week of inpatient stay.
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.
Measured: Daily over approximately 1 week of inpatient stay.
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.
Measured: Daily over approximately 1 week of inpatient stay.
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.
Measured: Daily over approximately 1 week of inpatient stay.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start1 Sep 2019
- Primary completion5 May 2021
- Study completion5 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Methamphetamine Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Craig Rush
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Craig Rush, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04178993
- Sponsor's protocol ID
- BED(IN):40
- Other IDs
- R01DA047391
- Status last verified
- Dec 2022
- First submitted
- 9 Aug 2019
- Last updated
- 9 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Drug Combination as a Pharmacotherapeutic for Methamphetamine-Use Disorder
- ClinicalTrials.gov ID
- NCT04178993
- Acronym / sponsor ID
- BED(IN):40
- Conditions
- Methamphetamine Use Disorder
- Keywords
- Methamphetamine, Methylphenidate, Duloxetine Hydrochloride, Central Nervous System Stimulants, Physiological Effects of Drugs, Dopamine Uptake Inhibitors, Serotonin and Noradrenaline Reuptake Inhibitors, Membrane Transport Modulators
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Craig RushUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 5 May 2021 (actual)
- Study completion
- 5 May 2021 (actual)
- First posted
- 26 Nov 2019 (actual)
- Results
- Posted 9 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Comparator: Placebo | Placebo comparator | Drug: Methamphetamine, Drug: Methylphenidate, Drug: Placebo oral capsuleSubjects 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. |
| Active Comparator: Duloxetine | Active comparator | Drug: Methamphetamine, Drug: Methylphenidate, Drug: Placebo oral capsule, Drug: DuloxetineSubjects 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- recent use of inhaled (i.e., snorted), smoked or injected methamphetamine
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethamphetamineAlso: MetamfetamineIn each arm, subjects will receive doses of methamphetamine. | Drug | Active Comparator: Duloxetine, Placebo Comparator: Placebo |
| MethylphenidateAlso: Metadate®In each arm, subjects will receive methylphenidate capsules. | Drug | Active Comparator: Duloxetine, Placebo Comparator: Placebo |
| Placebo oral capsuleAlso: LactoseIn each arm, subjects will receive placebo capsules. | Drug | Active Comparator: Duloxetine, Placebo Comparator: Placebo |
| DuloxetineAlso: Cymbalta®Subjects will receive duloxetine capsules in the duloxetine arm. | Drug | Active Comparator: Duloxetine |
Primary outcome
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 (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).
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).
28 secondary outcomes
Heart Rate After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.
Time frame: Daily over approximately 1 week of inpatient stay.
Heart Rate After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.
Time frame: Daily over approximately 1 week of inpatient stay.
Heart Rate After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.
Time frame: Daily over approximately 1 week of inpatient stay.
Heart Rate After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.
Time frame: Daily over approximately 1 week of inpatient stay.
Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.
Time frame: Daily over approximately 1 week of inpatient stay.
Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.
Time frame: Daily over approximately 1 week of inpatient stay.
Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.
Time frame: Daily over approximately 1 week of inpatient stay.
Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.
Time frame: Daily over approximately 1 week of inpatient stay.
Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.
Time frame: Daily over approximately 1 week of inpatient stay.
Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.
Time frame: Daily over approximately 1 week of inpatient stay.
Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.
Time frame: Daily over approximately 1 week of inpatient stay.
Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.
Time frame: Daily over approximately 1 week of inpatient stay.
Temperature After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.
Time frame: Daily over approximately 1 week of inpatient stay.
Temperature After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.
Time frame: Daily over approximately 1 week of inpatient stay.
Temperature After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.
Time frame: Daily over approximately 1 week of inpatient stay.
Temperature After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.
Time frame: Daily over approximately 1 week of inpatient stay.
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Time frame: Daily over approximately 1 week of inpatient stay.
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Time frame: Daily over approximately 1 week of inpatient stay.
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Time frame: Daily over approximately 1 week of inpatient stay.
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Time frame: Daily over approximately 1 week of inpatient stay.
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Time frame: Daily over approximately 1 week of inpatient stay.
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Time frame: Daily over approximately 1 week of inpatient stay.
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Time frame: Daily over approximately 1 week of inpatient stay.
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Time frame: Daily over approximately 1 week of inpatient stay.
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Time frame: Daily over approximately 1 week of inpatient stay.
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Time frame: Daily over approximately 1 week of inpatient stay.
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Time frame: Daily over approximately 1 week of inpatient stay.
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Time frame: Daily over approximately 1 week of inpatient stay.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Methamphetamine, Methylphenidate and Duloxetine in people with Methamphetamine Use Disorder, run by Craig Rush at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2023.