Methamphetamine-dependencePhase 1/2STAMPOUTNCT03336866

Study of Antibody for Methamphetamine Outpatient Therapy

A Phase 1/2 study testing IXT-m200 in people with Methamphetamine-dependence and Methamphetamine Abuse, run by InterveXion Therapeutics, LLC at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study evaluates the ability of IXT-m200 to change methamphetamine concentrations in blood and alter the way methamphetamine feels. Participants will receive either placebo, a low or high dose of IXT-m200, in addition to methamphetamine challenge doses. Read more about this study

Who is it for?: Ages 21 to 50 years
Conditions the study is for: Methamphetamine-dependence, Methamphetamine Abuse
What is being tested?: IXT-m200
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 77 participants
Where: 2 sitesUnited States
Study dates: 3 May 2018to 9 Mar 2021
Phase: Phase 1/2
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 21 to 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Subject voluntarily agrees to participate in this study and signs an informed consent form.
Subject must be able to verbalize understanding of the consent forms, provide written informed consent, and verbalize willingness to complete study procedures.
Males or females between 21 to 50 years of age, inclusive. Female subjects should be of non-childbearing potential or, they should be nonpregnant, nonlactating, and agree to use medically acceptable forms of birth control from screening to end-of-study follow-up, or have a partner who has had a vasectomy. Male subjects need to have had a vasectomy or agree to use a condom and spermicide in addition to their female partners using a form of birth control. They should agree not to donate sperm for 90 days post IXT-m200 dose.
Body mass index (BMI) between 18.0 and 35.0 kg/m2. Body weight ≥ 50 kg and ≤ 100 kg.
Subjects have hematology and chemistry laboratory tests that are within normal (+/- 10%) limits with the following exceptions: a) liver function tests (total bilirubin, alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase) < 3 times the upper limit of normal, and b) kidney function tests (creatinine and BUN) < 2 times the upper limit of normal.
Subjects meet Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for METH use disorder and are not seeking treatment at the time of the study.

Show all 11Show fewer

Subjects will be experienced METH users with a history of non-therapeutic METH use for 2 or more years. Subjects must have experience with smoking or IV injection of METH.
Current METH use (past 30 days) less than daily, self-reported and documented by calendar-based timeline follow-back.
Primary current (past 30 days) route of METH self-administration other than IV (ie, smoking, snorting, or oral).
Subjects agree not to take METH from any source outside of the study during their participation in the study. Subjects agree not to take substances that are structurally similar to METH.
Subjects must provide a negative urine sample prior to admission to the unit on Day -1 for the study.

Who cannot join

Subjects who have been treated with a monoclonal antibody (mAb) in the past year.
Known or suspected allergy sensitivity to IXT-m200 based on known allergies to other mAbs.
History of severe allergy (rash, hives, breathing difficulty, etc) to any medications.
History of allergic or environmental bronchial asthma.
Clinically significant history of or current abnormality or disease of any organ system, including renal, hepatic, GI, cardiovascular, pulmonary (including chronic asthma), endocrine (eg, diabetes), central nervous, or hematologic systems, or recent clinically significant surgery.
Current diagnosis or history of major psychiatric illness in the past two years or other current psychiatric condition requiring medication, other than methamphetamine dependence.

Show all 21Show fewer

Considered by the PI to be at imminent risk of suicide or injury to self, others, or property, or the subject has attempted suicide with the past year. Past year history of, or current evidence for, suicidal ideation or those who were actively suicidal based on the Columbia-Suicide Severity Rating Scale (C-SSRS).
Current dependence on alcohol or heavy use defined as >28 alcoholic drinks per week if male and >21 drinks per week if female in last 30 days.
Current dependence on other drugs except amphetamines, or marijuana and nicotine used in moderate amounts.
History of seizure, epilepsy, severe head injury with residual neurologic effects, multiple sclerosis, or stroke.
Abnormal pre-admission vital signs, physical examination, clinical laboratory, ECG, or any safety variable which is considered clinically significant for this population.
History of cardiovascular disease.
Treatment with any prescription medications or over the counter nutritional supplements within 14 days prior to the first dose of study medication.
Ingestion of any approved prescription anti-obesity drug or taken any over-the-counter medication for weight loss within a period of 90 days prior to the first dose of study medication.
Ingestion or use of any investigational medication or device within 30 days prior to the first dose of study medication.
Acute illness within 5 days prior to the first dose of study medication, eg, flu syndrome, GI virus, or clinically significant indigestion (eg, reflux).
Positive result for hepatitis B surface antigen (HBsAG), hepatitis C (HepC) antibody, hepatitis A immunoglobulin M (IgM), or HIV Viral Serology, or nucleic acid testing (NAT) tests at screening.
Positive breath alcohol test or positive urine drug test for illicit substances on Day -1.
Subjects with history of donated blood, plasma, or platelets in last 30 days, and who do not agree to refrain from blood, plasma, platelets, egg or sperm donation during the study period.
Predominant or only route of METH self-administration is IV.
Any subject judged by the PI or Sponsor (or designee) to be inappropriate for the study.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Anaheim Clinical Trials
Anaheim, California, 92801
PRA Health Sciences
Salt Lake City, Utah, 84124

Other trials in United States

About this study

Official title: STAMPOUT: Study of Antibody for Methamphetamine Outpatient Therapy

Read the detailed description

IXT-m200 is a monoclonal antibody that binds to methamphetamine in the blood. The main purpose of this study is to look at the effects of IXT-m200 on the pharmacokinetics of methamphetamine and on methamphetamine liking effects. Additionally, the study will determine IXT-m200 pharmacokinetics, safety and tolerability in subjects with methamphetamine use disorder. Qualified subjects will receive a single dose of IXT-m200 followed by up to 4 methamphetamine challenge doses.

Conditions: Methamphetamine-dependence, Methamphetamine Abuse
Being tested: Placebo, IXT-m200

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
Normal saline
IXT-m200Drug
Also called ch-mAb7F9
IXT-m200 is an anti-methamphetamine monoclonal antibody

Study groups in NCT03336866
Study group	Role	What they receive
Placebo	Placebo comparator	Normal saline Receives: Drug: Placebo
IXT-m200	Experimental	Single 6 or 20 mg/kg intravenous dose of IXT-m200 Receives: Drug: IXT-m200

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Plasma Methamphetamine (METH) Area Under the Curve (AUCinf) Resulting From METH Challenge Doses Following Single IV Doses of IXT-m200
METH AUCinf following IXT-m200 dosing on each METH Challenge Day.
Measured: Day 1, 5, 12, 19, and 26
Change in Plasma Methamphetamine (METH) Maximum Concentration (Cmax) Resulting From METH Challenge Doses Following Single IV Doses of IXT-m200
METH Cmax following IXT-m200 dosing on each METH Challenge Day.
Measured: Day 1, 5, 12, 19, and 26

Secondary outcomes (10)

Change in Subjective Effects for CRAVE of METH Challenge Doses
Drug effects questionnaires (visual analog scales with range from 0 (no effect) to 100 (maximum effect)) were administered following weekly doses of methamphetamine starting on Day 5, one day after IXT-m200 or placebo administration. Participants were asked questions assessing subjective effects for CRAVE over 180 minutes. Values were calculated as an area under the curve by using the trapezoidal rule; time 0 was set to 0 on the effect scale (at time of methamphetamine administration) and the area was calculated through 180 min post-dose. Lower values would indicate less drug effect (better) than higher values indicating larger drug effect (worse).
Measured: Day 1, 5, 12, 19, and 26
Change in Subjective Effects for DISLIKE of METH Challenge Doses
Drug effects questionnaires (visual analog scales with range from 0 (no effect) to 100 (maximum effect)) were administered following weekly doses of methamphetamine starting on Day 5, one day after IXT-m200 or placebo administration. Participants were asked questions assessing subjective effects for DISLIKE over 180 minutes. Values were calculated as an area under the curve by using the trapezoidal rule; time 0 was set to 0 on the effect scale (at time of methamphetamine administration) and the area was calculated through 180 min post-dose. Lower values would indicate less drug effect (better) than higher values indicating larger drug effect (worse).
Measured: Day 1, 5, 12, 19, and 26
Change in Subjective Effects for FEEL of METH Challenge Doses
Drug effects questionnaires (visual analog scales with range from 0 (no effect) to 100 (maximum effect)) were administered following weekly doses of methamphetamine starting on Day 5, one day after IXT-m200 or placebo administration. Participants were asked questions assessing subjective effects for FEEL over 180 minutes. Values were calculated as an area under the curve by using the trapezoidal rule; time 0 was set to 0 on the effect scale (at time of methamphetamine administration) and the area was calculated through 180 min post-dose. Lower values would indicate less drug effect (better) than higher values indicating larger drug effect (worse).
Measured: Day 1, 5, 12, 19, and 26
Change in Subjective Effects for GOOD of METH Challenge Doses
Drug effects questionnaires (visual analog scales with range from 0 (no effect) to 100 (maximum effect)) were administered following weekly doses of methamphetamine starting on Day 5, one day after IXT-m200 or placebo administration. Participants were asked questions assessing subjective effects for GOOD over 180 minutes. Values were calculated as an area under the curve by using the trapezoidal rule; time 0 was set to 0 on the effect scale (at time of methamphetamine administration) and the area was calculated through 180 min post-dose. Lower values would indicate less drug effect (better) than higher values indicating larger drug effect (worse).
Measured: Day 1, 5, 12, 19, and 26
Change in Subjective Effects for HIGH of METH Challenge Doses
Drug effects questionnaires (visual analog scales with range from 0 (no effect) to 100 (maximum effect)) were administered following weekly doses of methamphetamine starting on Day 5, one day after IXT-m200 or placebo administration. Participants were asked questions assessing subjective effects for HIGH over 180 minutes. Values were calculated as an area under the curve by using the trapezoidal rule; time 0 was set to 0 on the effect scale (at time of methamphetamine administration) and the area was calculated through 180 min post-dose. Lower values would indicate less drug effect (better) than higher values indicating larger drug effect (worse).
Measured: Day 1, 5, 12, 19, and 26
Change in Subjective Effects for LIKE of METH Challenge Doses
Drug effects questionnaires (visual analog scales with range from 0 (no effect) to 100 (maximum effect)) were administered following weekly doses of methamphetamine starting on Day 5, one day after IXT-m200 or placebo administration. Participants were asked questions assessing subjective effects for LIKE over 180 minutes. Values were calculated as an area under the curve by using the trapezoidal rule; time 0 was set to 0 on the effect scale (at time of methamphetamine administration) and the area was calculated through 180 min post-dose. Lower values would indicate less drug effect (better) than higher values indicating larger drug effect (worse).
Measured: Day 1, 5, 12, 19, and 26
Change in Subjective Effects for MORE of METH Challenge Doses
Drug effects questionnaires (visual analog scales with range from 0 (no effect) to 100 (maximum effect)) were administered following weekly doses of methamphetamine starting on Day 5, one day after IXT-m200 or placebo administration. Participants were asked questions assessing subjective effects for MORE over 180 minutes. Values were calculated as an area under the curve by using the trapezoidal rule; time 0 was set to 0 on the effect scale (at time of methamphetamine administration) and the area was calculated through 180 min post-dose. Lower values would indicate less drug effect (better) than higher values indicating larger drug effect (worse).
Measured: Day 1, 5, 12, 19, and 26
Change in Subjective Effects for STIMULATED of METH Challenge Doses
Drug effects questionnaires (visual analog scales with range from 0 (no effect) to 100 (maximum effect)) were administered following weekly doses of methamphetamine starting on Day 5, one day after IXT-m200 or placebo administration. Participants were asked questions assessing subjective effects for STIMULATED over 180 minutes. Values were calculated as an area under the curve by using the trapezoidal rule; time 0 was set to 0 on the effect scale (at time of methamphetamine administration) and the area was calculated through 180 min post-dose. Lower values would indicate less drug effect (better) than higher values indicating larger drug effect (worse).
Measured: Day 1, 5, 12, 19, and 26
Safety and Tolerability of IXT-m200 Followed by METH Challenges
Number of serious adverse events (SAEs) as identified by physical examinations and vital sign, adverse event, ECG, and clinical laboratory testing, and immune response by measurement of anti-IXT-m200 antibody levels.
Measured: 126 days
Pharmacokinetics of IXT-m200 Following Single Administration
Measured by serum concentrations of IXT-m200 over time
Measured: 122 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 May 20189 Mar 2021

First posted8 Nov 2017
Study start3 May 2018
Primary completion23 Nov 2020
Study completion9 Mar 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-dependenceStudies 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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 77 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03336866
Sponsor's protocol ID: M200C-1801
Other IDs: U01DA045366
Acronym: STAMPOUT
Status last verified: Jan 2022
First submitted: 6 Nov 2017
Last updated: 10 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Final datasets are expected to contain pharmacokinetic data on IXT-m200 and METH, subjective effects data, immunogenicity totals, and safety data. No individually identifiable private information will be distributed.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: STAMPOUT: Study of Antibody for Methamphetamine Outpatient Therapy
ClinicalTrials.gov ID: NCT03336866
Acronym / sponsor ID: STAMPOUT / M200C-1801
Conditions: Methamphetamine-dependence, Methamphetamine Abuse
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 77 participants (actual)
Lead sponsor: InterveXion Therapeutics, LLCIndustry (pharma, biotech, devices)
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 3 May 2018 (actual)
Primary completion: 23 Nov 2020 (actual)
Study completion: 9 Mar 2021 (actual)
First posted: 8 Nov 2017 (actual)
Results: Posted 10 Mar 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboNormal saline
IXT-m200	Experimental	Drug: IXT-m200Single 6 or 20 mg/kg intravenous dose of IXT-m200

Who may qualify

Ages: 21 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (11 listed)

Subject voluntarily agrees to participate in this study and signs an informed consent form.
Subject must be able to verbalize understanding of the consent forms, provide written informed consent, and verbalize willingness to complete study procedures.
Males or females between 21 to 50 years of age, inclusive. Female subjects should be of non-childbearing potential or, they should be nonpregnant, nonlactating, and agree to use medically acceptable forms of birth control from screening to end-of-study follow-up, or have a partner who has had a vasectomy. Male subjects need to have had a vasectomy or agree to use a condom and spermicide in addition to their female partners using a form of birth control. They should agree not to donate sperm for 90 days post IXT-m200 dose.
Body mass index (BMI) between 18.0 and 35.0 kg/m2. Body weight ≥ 50 kg and ≤ 100 kg.
Subjects have hematology and chemistry laboratory tests that are within normal (+/- 10%) limits with the following exceptions: a) liver function tests (total bilirubin, alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase) < 3 times the upper limit of normal, and b) kidney function tests (creatinine and BUN) < 2 times the upper limit of normal.

Key exclusion criteria (21 listed)

Subjects who have been treated with a monoclonal antibody (mAb) in the past year.
Known or suspected allergy sensitivity to IXT-m200 based on known allergies to other mAbs.
History of severe allergy (rash, hives, breathing difficulty, etc) to any medications.
History of allergic or environmental bronchial asthma.
Clinically significant history of or current abnormality or disease of any organ system, including renal, hepatic, GI, cardiovascular, pulmonary (including chronic asthma), endocrine (eg, diabetes), central nervous, or hematologic systems, or recent clinically significant surgery.

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
PlaceboNormal saline	Drug	Placebo
IXT-m200Also: ch-mAb7F9IXT-m200 is an anti-methamphetamine monoclonal antibody	Drug	IXT-m200

Primary outcome

Change in Plasma Methamphetamine (METH) Area Under the Curve (AUCinf) Resulting From METH Challenge Doses Following Single IV Doses of IXT-m200
Time frame: Day 1, 5, 12, 19, and 26
METH AUCinf following IXT-m200 dosing on each METH Challenge Day.
Change in Plasma Methamphetamine (METH) Maximum Concentration (Cmax) Resulting From METH Challenge Doses Following Single IV Doses of IXT-m200
Time frame: Day 1, 5, 12, 19, and 26
METH Cmax following IXT-m200 dosing on each METH Challenge Day.

10 secondary outcomes

Change in Subjective Effects for CRAVE of METH Challenge Doses
Time frame: Day 1, 5, 12, 19, and 26
Change in Subjective Effects for DISLIKE of METH Challenge Doses
Time frame: Day 1, 5, 12, 19, and 26
Change in Subjective Effects for FEEL of METH Challenge Doses
Time frame: Day 1, 5, 12, 19, and 26
Change in Subjective Effects for GOOD of METH Challenge Doses
Time frame: Day 1, 5, 12, 19, and 26
Change in Subjective Effects for HIGH of METH Challenge Doses
Time frame: Day 1, 5, 12, 19, and 26
Change in Subjective Effects for LIKE of METH Challenge Doses
Time frame: Day 1, 5, 12, 19, and 26
Change in Subjective Effects for MORE of METH Challenge Doses
Time frame: Day 1, 5, 12, 19, and 26
Change in Subjective Effects for STIMULATED of METH Challenge Doses
Time frame: Day 1, 5, 12, 19, and 26
Safety and Tolerability of IXT-m200 Followed by METH Challenges
Time frame: 126 days
Pharmacokinetics of IXT-m200 Following Single Administration
Time frame: 122 days

Results and safety

Results posted to the registry on 10 Mar 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	20	17
IXT-m200, 6 mg/kg	18	17
IXT-m200, 20 mg/kg	18	14

Primary outcome: Change in Plasma Methamphetamine (METH) Area Under the Curve (AUCinf) Resulting From METH Challenge Doses Following Single IV Doses of IXT-m200

Time frame: Day 1, 5, 12, 19, and 26. Mean (Standard Deviation). Unit: h*ng/mL

Measure	Placebo n = 20	IXT-m200, 6 mg/kg n = 18	IXT-m200, 20 mg/kg n = 18
Day 1, AUCinf	1635 (1345)	1433 (555)	1265 (350)
Day 5, AUCinf	1233 (323)	14042 (3067)	39379 (8288)
Day 12, AUCinf	1254 (341)	8210 (2184)	21846 (3915)
Day 19, AUCinf	1219 (346)	5640 (1123)	16458 (2580)
Day 26, AUCinf	1225 (389)	4336 (1021)	12411 (2597)

Placebo vs IXT-m200, 6 mg/kg: p <0.0001, Mixed Models Analysis
Placebo vs IXT-m200, 6 mg/kg: p <0.0001, Mixed Models Analysis
Placebo vs IXT-m200, 6 mg/kg: p <0.0001, Mixed Models Analysis

Population analysed: This outcome used the pharmacokinetic (PK) set. The PK set consisted of all subjects in the safety analysis set for whom at least 1 PK parameter could be calculated for METH or IXT-m200.

Primary outcome: Change in Plasma Methamphetamine (METH) Maximum Concentration (Cmax) Resulting From METH Challenge Doses Following Single IV Doses of IXT-m200

Time frame: Day 1, 5, 12, 19, and 26. Mean (Standard Deviation). Unit: ng/mL

Measure	Placebo n = 20	IXT-m200, 6 mg/kg n = 18	IXT-m200, 20 mg/kg n = 18
Day 1, Cmax	111 (58)	98 (29)	90 (24)
Day 5, Cmax	103 (56)	312 (37)	759 (135)
Day 12, Cmax	100 (31)	198 (24)	444 (92)
Day 19, Cmax	96 (36)	168 (24)	340 (57)
Day 26, Cmax	80 (13)	145 (17)	262 (54)

Placebo vs IXT-m200, 6 mg/kg: p <0.0001, Mixed Models Analysis
Placebo vs IXT-m200, 6 mg/kg: p <0.0001, Mixed Models Analysis
Placebo vs IXT-m200, 6 mg/kg: p <0.0001, Mixed Models Analysis

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: 126 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Subjects: Day 1-3	0 of 77 (0%)	69 of 77 (89.6%)	0 of 77
Placebo: Day 4-126	0 of 20 (0%)	20 of 20 (100%)	0 of 20
IXT-m200, 6 mg/kg: Day 4-126	0 of 18 (0%)	17 of 18 (94.4%)	0 of 18
IXT-m200, 20 mg/kg: Day 4-126	0 of 18 (0%)	18 of 18 (100%)	0 of 18

Limitations and caveats (from the sponsor): All participants were dosed with methamphetamine on a weekly basis following treatment with IXT-m200 or placebo. Thus, safety of IXT-m200 alone cannot be distinguished from the expected adverse events resulting from the methamphetamine doses. Variability of the responses on the drug effects questionnaires was much higher than anticipated. This resulted in insufficient power to detect differences between treated and control groups.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Final datasets are expected to contain pharmacokinetic data on IXT-m200 and METH, subjective effects data, immunogenicity totals, and safety data. No individually identifiable private information will be distributed.

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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.

Lynn Webster, MD principal investigator

PRA Health Sciences

Peter Winkle, MD principal investigator

Anaheim Clinical Trials

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing IXT-m200 in people with Methamphetamine-dependence and Methamphetamine Abuse, run by InterveXion Therapeutics, LLC 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 11 inclusion and 21 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 10 Mar 2022. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 10 Mar 2022). 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?

Change in Plasma Methamphetamine (METH) Area Under the Curve (AUCinf) Resulting From METH Challenge Doses Following Single IV Doses of IXT-m200 (time frame: Day 1, 5, 12, 19, and 26). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03336866.

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 10 Mar 2022.