Methamphetamine DependencePhase 1NCT00519259
Tolerability and Safety of 30, 45, and 60 mg of Sublingual Lobeline. - 1
A Phase 1 study testing Lobeline in people with Methamphetamine Dependence, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
The purpose of this study is to assess safety and pharmacokinetics of sublingual lobeline in healthy normal volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Methamphetamine Dependence
- What is being tested?
- Lobeline
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must be able to provide written informed consent
- Must have a body mass index between 18 and 30
- Have no medical contraindications as determined by medical history, physical exam, ECG, hematology and blood chemistry profile, and urinalysis
- Must have a negative drug test at screening and admission
- If female of child bearing potential, must agree to use birth control
Who cannot join
- Please contact the site for more information
Trial locations and contacts
1 site in 1 country.
United States1 site
Langley Porter Psychiatric Institute
San Francisco, California, 94143
About this study
Official title: Tolerability, Safety, and Pharmacokinetics of Repeated Sublingual Doses of Lobeline
The purpose of this study is to assess safety and pharmacokinetics of sublingual lobeline in healthy normal volunteers.
- Conditions
- Methamphetamine Dependence
- Being tested
- Lobeline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LobelineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability
Secondary outcomes (4)
Safety
Pharmacokinetic parameters
Cardiovascular responses
Psychological effects of lobeline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2007 (estimated)
- Study startFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 12 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Reese Jones, M.D., Principal investigator, Langley Porter Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00519259
- Sponsor's protocol ID
- NIDA-CPU-0009-1
- Status last verified
- Jun 2006
- First submitted
- 29 Jun 2006
- Last updated
- 11 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerability, Safety, and Pharmacokinetics of Repeated Sublingual Doses of Lobeline
- ClinicalTrials.gov ID
- NCT00519259
- Acronym / sponsor ID
- NIDA-CPU-0009-1
- Conditions
- Methamphetamine Dependence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Feb 2006
- First posted
- 22 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess safety and pharmacokinetics of sublingual lobeline in healthy normal volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Must be able to provide written informed consent
- Must have a body mass index between 18 and 30
- Have no medical contraindications as determined by medical history, physical exam, ECG, hematology and blood chemistry profile, and urinalysis
- Must have a negative drug test at screening and admission
- If female of child bearing potential, must agree to use birth control
Key exclusion criteria (1 listed)
- Please contact the site for more information
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 |
|---|---|---|
| Lobeline | Drug | – |
Primary outcome
Tolerability
4 secondary outcomes
Safety
Pharmacokinetic parameters
Cardiovascular responses
Psychological effects of lobeline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
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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.
Reese Jones, M.D. principal investigator
Langley Porter Psychiatric Institute
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 testing Lobeline in people with Methamphetamine Dependence, run by National Institute on Drug Abuse (NIDA) 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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Jan 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. 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?
Results are not available in the source record.
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?
Tolerability. 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 11 Jan 2017.