Methamphetamine AbusePhase 1NCT01019707
Safety Assessment of Atomoxetine With MA IV Administration
A Phase 1 study of Methamphetamine Abuse and Methamphetamine Dependence, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This is a study of 4 nontreatment seeking individuals who were MA-dependent and the safety and tolerability of atomoxetine. This double-blind, placebo-controlled, within-subjects study is to determine the safety and tolerability of atomoxetine. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Methamphetamine Abuse, Methamphetamine Dependence
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Dec 2010
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Be fluently English-speaking volunteers who meet DSM-IV criteria for MA abuse or dependence.
- Be between 18 and 50 years of age.
- Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures.
- Have smoked or injected methamphetamine for more than two years.
- Produce a methamphetamine-positive urine prior to study entry.
- Have vital signs as follows: resting pulse between 50 and 90 bpm, blood pressures between 105-150mm Hg systolic and 45-90mm Hg diastolic. Note that a blood pressure of 150/90 and pulse of 90 is too high for randomization but will allow participants to be enrolled if an acceptable range is demonstrated on a separate occasion.
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- Have an ECG performed that demonstrates normal sinus rhythm, normal conduction, and no clinically significant arrhythmias.
- Agree to abstain from MA during the study, evidenced by a MA-negative urine each morning of the study.
- If female, have a negative pregnancy test and agree to use one of the following methods of birth control, or be postmenopausal, have had a hysterectomy or have been sterilized.
- oral contraceptives
- barrier (diaphragm or condom) with spermicide, or condom only
- intrauterine progesterone,or non-hormonal contraceptive system
- levonorgestrel implant
- medroxyprogesterone acetate contraceptive injection
- complete abstinence from sexual intercourse
- NOTE: Recent intermittent alcohol or other illicit drug use without physical dependence is allowable (however a benzodiazepine-free urine should be produced to document absence of recent use).
Who cannot join
- A current or past history of seizure disorder, including alcohol- or stimulant-related seizure, febrile seizure, or significant family history of idiopathic seizure disorder.
- A history of head trauma that resulted in neurological sequelae (e.g., with loss of consciousness [LOC] > 15 minutes, or that required hospitalization. Also, individuals with 3 or more head injuries with LOC > 5 minutes will be excluded).
- Do not meet DSM-IV criteria (by SCID) for drug dependence other than meth, with the exception of nicotine and/or marijuana dependence.
- Any previous medically serious adverse reaction to MA including loss of consciousness, chest pain, or epileptic seizure resulting in hospitalization.
- Meeting diagnostic criteria or receiving psychopharmacological treatment for the following Axis I disorders within the last 6 months: anorexia nervosa, bulimia, psychosis, bipolar I disorder, organic brain disease, dementia, major depression, schizoaffective disorder, or schizophrenia.
- Evidence of clinically significant heart disease, hypertension or significant medical illness.
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- Have any history of hypersensitivity to atomoxetine, glaucoma, motor tics or with a family history or diagnosis of Tourette's syndrome.
- Have any preexisting severe gastrointestinal narrowing, small bowel inflammatory disease, intestinal adhesions, past history of peritonitis, or cystic fibrosis.
- Be pregnant or nursing.
- Have a significant family history of early cardiovascular morbidity or mortality.
- Have a diagnosis of adult asthma, including those with a history of acute asthma within the past two years, and those with current or recent (past 2 years) treatment with inhaled or oral beta-agonist or steroid therapy (due to potential serious adverse interactions with methamphetamine).
- Be actively using albuterol or other beta agonist medications, regardless of formal diagnosis of asthma. (Inhalers are sometimes used by MA addicts to enhance MA delivery to the lungs.) If respiratory disease is excluded and the subject will consent to discontinue agonist use, s/he may be considered for inclusion.
- For subjects suspect for asthma but without formal diagnosis, 1) have a history of coughing and/or wheezing, 2) have a history of asthma and/or asthma treatment two or more years before, 3) have a history of other respiratory illness, e.g., complications of pulmonary disease (exclude if on beta agonists), 4) use over-the-counter agonist or allergy medication for respiratory problems (e.g., Primatene Mist): a detailed history and physical exam, pulmonary consult, and pulmonary function tests should be performed prior to including or excluding from the study or 5) have an FEV1 <70 %.
- Have any illness, condition, and/or use of medications that in the opinion of the site Principal Investigator and the admitting physician would preclude safe and/or successful completion of the study.
- Have active syphilis that has not been treated or refuse treatment for syphilis.
- Be undergoing HIV treatment with antiviral and non-antiviral therapy.
- Have AIDS according to the current CDC criteria for AIDS - MMWR 1999;48 (#RR-13:29-31).
- Have neurological disorders including Parkinson's disease.
- Have evidence of significant liver or kidney dysfunction.
- Have a history of urinary retention or bladder outlet obstruction.
- Be UCLA students or staff.
- Have evidence of active tuberculosis infection.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Semel Institute NPI
Los Angeles, California, 90095
About this study
Official title: A Study to Assess the Cardiovascular, Cognitive and Subjective Effects of Atomoxetine in Combination With Intravenous Methamphetamine
This is a study of 4 nontreatment seeking individuals who were MA-dependent and the safety and tolerability of atomoxetine. This double-blind, placebo-controlled, within-subjects study is to determine the safety and tolerability of atomoxetine.
MA abusing participants will undergo a 1-day outpatient screening and if it is safe for the participants to proceed with the study they will participate in two inpatient components of the study that will occur in the University of California Los Angeles (UCLA) General Clinical Research Center (GCRC). The first inpatient stay will be 15 days, and the second will be a 9 days stay that includes drug administration and assessments. There will be at least a two week interval between inpatient components. During the inpatient components participants will receive alternating study drugs; atomoxetine or placebo and four sessions of IV MA administration or saline.
Read the detailed description
The safety of using atomoxetine in MA users will be characterized by measuring the cardiovascular effects of MA and by determining the occurrence of adverse reactions during treatment with atomoxetine and placebo. We will evaluate atomoxetine (0 and 40 mg, BID) and MA doses (0 and 30 mg, IV).
Participants will be randomized to atomoxetine or matched placebo for 6 days. Study drug will be administered once daily at 40 mg/day on the first two study days, twice daily for days 3-5, \& once on day 6. After discharge from the first component, and at least a 2-week washout period, participants will be re-admitted to the UCLA GCRC and switched to the opposite study medication for an additional 6 days.
Methamphetamine/saline will be administered non-contingently on component I day 13, and component II day 7, over 1 min using a syringe pump activated by the study physician or nurse practitioner in order to assess safety and tolerability of atomoxetine. During drug administration sessions, heart rate and blood pressure will be monitored frequently. A code team will respond if required. Vital signs must remain within values specified under Stopping Criteria for initiation of MA administration. The physician or nurse practitioner will administer the MA/placebo and will be available in-house on pager for at least 4 h after each infusion. In addition, heart rate and blood pressure will be assessed three times daily throughout the inpatient portion of the protocol.
- Conditions
- Methamphetamine Abuse, Methamphetamine Dependence
- Being tested
- Atomoxetine, then Placebo, Placebo, then Atomoxetine
- Keywords
- crystal meth, methamphetamine, substance abuse
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atomoxetine, then PlaceboDrug
Also called Strattera
As this is a within-subject, crossover design, all subjects complete both study medication assignments in a double-blind fashion. Based on random assignment to start on either atomoxetine or placebo, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day.
Placebo, then AtomoxetineDrug
As this is a within-subject, crossover design, all subjects complete both study medication assignments in a double-blind fashion. Based on random assignment to start on either atomoxetine or placebo, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day.
| Study group | Role | What they receive |
|---|---|---|
| Sugar pill | Placebo comparator | As this is a within-subject, crossover design, all subjects complete both study medication assignments in a double-blind fashion. Based on random assignment to start on either atomoxetine or placebo, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Receives: Drug: Atomoxetine, then Placebo; Drug: Placebo, then Atomoxetine |
| Atomoxetine | Active comparator | As this is a within-subject, crossover design, all subjects complete both study medication assignments in a double-blind fashion. Based on random assignment to start on either atomoxetine or placebo, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Receives: Drug: Atomoxetine, then Placebo; Drug: Placebo, then Atomoxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure
Based on 8 timepoints post MA infusion, data were pooled and the mean value and standard deviation are presented. Timepoints assessed were collected at 2, 5, 10, 15, 30, 45, 60, 90 minutes following infusion.
Measured: Timepoints post MA infusion
Diastolic Blood Pressure
Based on 8 timepoints post MA infusion, data were pooled and the mean value and standard deviation are presented. Timepoints assessed were collected at 2, 5, 10, 15, 30, 45, 60, 90 minutes following infusion.
Measured: Timepoints post MA infusion
Heart Rate
Based on 8 timepoints post MA infusion, data were pooled and the mean value and standard deviation are presented. Timepoints assessed were collected at 2, 5, 10, 15, 30, 45, 60, 90 minutes following infusion.
Measured: Timepoints post MA infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionDec 2010
- Study completionDec 2010
Why it stopped: End in funding
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 AbuseStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Steve Shoptaw, University of California, Los Angeles
- Investigators
- Steven Shoptaw, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01019707
- Sponsor's protocol ID
- P50-18185-PI-EDL-A
- Other IDs
- P50DA018185, DPMC
- Status last verified
- May 2017
- First submitted
- 24 Nov 2009
- Last updated
- 2 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Cardiovascular, Cognitive and Subjective Effects of Atomoxetine in Combination With Intravenous Methamphetamine
- ClinicalTrials.gov ID
- NCT01019707
- Acronym / sponsor ID
- P50-18185-PI-EDL-A
- Conditions
- Methamphetamine Abuse, Methamphetamine Dependence
- Keywords
- crystal meth, methamphetamine, substance abuse
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: End in funding
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Oct 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 25 Nov 2009 (estimated)
- Results
- Posted 31 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study of 4 nontreatment seeking individuals who were MA-dependent and the safety and tolerability of atomoxetine. This double-blind, placebo-controlled, within-subjects study is to determine the safety and tolerability of atomoxetine.
MA abusing participants will undergo a 1-day outpatient screening and if it is safe for the participants to proceed with the study they will participate in two inpatient components of the study that will occur in the University of California Los Angeles (UCLA) General Clinical Research Center (GCRC). The first inpatient stay will be 15 days, and the second will be a 9 days stay that includes drug administration and assessments. There will be at least a two week interval between inpatient components. During the inpatient components participants will receive alternating study drugs; atomoxetine or placebo and four sessions of IV MA administration or saline.
Detailed description
The safety of using atomoxetine in MA users will be characterized by measuring the cardiovascular effects of MA and by determining the occurrence of adverse reactions during treatment with atomoxetine and placebo. We will evaluate atomoxetine (0 and 40 mg, BID) and MA doses (0 and 30 mg, IV).
Participants will be randomized to atomoxetine or matched placebo for 6 days. Study drug will be administered once daily at 40 mg/day on the first two study days, twice daily for days 3-5, \& once on day 6. After discharge from the first component, and at least a 2-week washout period, participants will be re-admitted to the UCLA GCRC and switched to the opposite study medication for an additional 6 days.
Methamphetamine/saline will be administered non-contingently on component I day 13, and component II day 7, over 1 min using a syringe pump activated by the study physician or nurse practitioner in order to assess safety and tolerability of atomoxetine. During drug administration sessions, heart rate and blood pressure will be monitored frequently. A code team will respond if required. Vital signs must remain within values specified under Stopping Criteria for initiation of MA administration. The physician or nurse practitioner will administer the MA/placebo and will be available in-house on pager for at least 4 h after each infusion. In addition, heart rate and blood pressure will be assessed three times daily throughout the inpatient portion of the protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar pill | Placebo comparator | Drug: Atomoxetine, then Placebo, Drug: Placebo, then AtomoxetineAs this is a within-subject, crossover design, all subjects complete both study medication assignments in a double-blind fashion. Based on random assignment to start on either atomoxetine or placebo, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. |
| Atomoxetine | Active comparator | Drug: Atomoxetine, then Placebo, Drug: Placebo, then AtomoxetineAs this is a within-subject, crossover design, all subjects complete both study medication assignments in a double-blind fashion. Based on random assignment to start on either atomoxetine or placebo, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Be fluently English-speaking volunteers who meet DSM-IV criteria for MA abuse or dependence.
- Be between 18 and 50 years of age.
- Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures.
- Have smoked or injected methamphetamine for more than two years.
- Produce a methamphetamine-positive urine prior to study entry.
Key exclusion criteria (22 listed)
- A current or past history of seizure disorder, including alcohol- or stimulant-related seizure, febrile seizure, or significant family history of idiopathic seizure disorder.
- A history of head trauma that resulted in neurological sequelae (e.g., with loss of consciousness [LOC] > 15 minutes, or that required hospitalization. Also, individuals with 3 or more head injuries with LOC > 5 minutes will be excluded).
- Do not meet DSM-IV criteria (by SCID) for drug dependence other than meth, with the exception of nicotine and/or marijuana dependence.
- Any previous medically serious adverse reaction to MA including loss of consciousness, chest pain, or epileptic seizure resulting in hospitalization.
- Meeting diagnostic criteria or receiving psychopharmacological treatment for the following Axis I disorders within the last 6 months: anorexia nervosa, bulimia, psychosis, bipolar I disorder, organic brain disease, dementia, major depression, schizoaffective disorder, or schizophrenia.
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 |
|---|---|---|
| Atomoxetine, then PlaceboAlso: StratteraAs this is a within-subject, crossover design, all subjects complete both study medication assignments in a double-blind fashion. Based on random assignment to start on either atomoxetine or placebo, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. | Drug | Atomoxetine, Sugar pill |
| Placebo, then AtomoxetineAs this is a within-subject, crossover design, all subjects complete both study medication assignments in a double-blind fashion. Based on random assignment to start on either atomoxetine or placebo, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. | Drug | Atomoxetine, Sugar pill |
Primary outcome
Systolic Blood Pressure
Time frame: Timepoints post MA infusion
Based on 8 timepoints post MA infusion, data were pooled and the mean value and standard deviation are presented. Timepoints assessed were collected at 2, 5, 10, 15, 30, 45, 60, 90 minutes following infusion.
Diastolic Blood Pressure
Time frame: Timepoints post MA infusion
Based on 8 timepoints post MA infusion, data were pooled and the mean value and standard deviation are presented. Timepoints assessed were collected at 2, 5, 10, 15, 30, 45, 60, 90 minutes following infusion.
Heart Rate
Time frame: Timepoints post MA infusion
Based on 8 timepoints post MA infusion, data were pooled and the mean value and standard deviation are presented. Timepoints assessed were collected at 2, 5, 10, 15, 30, 45, 60, 90 minutes following infusion.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Steven Shoptaw, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Methamphetamine Abuse and Methamphetamine Dependence, run by University of California, Los Angeles at 1 site 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 16 inclusion and 22 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: stopped early, as of the sponsor's last update on 2 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 31 Jul 2013). 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?
Systolic Blood Pressure (time frame: Timepoints post MA infusion). The study lists 3 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 2 Jun 2017; AzTrials last refreshed its copy on 7 Nov 2026.