Methamphetamine DependencePhase 1NCT01359930
Phase 1 Naltrexone-Bupropion-Methamphetamine Interaction Study
A Phase 1 study testing Naltrexone and Bupropion SR in people with Methamphetamine Dependence, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
The study is to primarily measure safety and interactions between oral doses of Naltrexone/Bupropion and i.v. Methamphetamine. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Methamphetamine Dependence
- What is being tested?
- Naltrexone and Bupropion SR
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Jun 2012
- 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 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Are MA experienced but not dependent, males or females aged 21-to-50 years.
- Reported use of MA during the past six months without experiencing an adverse consequence plus a life time MA or amphetamine use history of at least four occasions of use.
- Have a body mass index (BMI) between 18 and 30.
- Are willing and able to give written consent.
- Are not currently a subject (including still in the follow-up period) of another drug research study.
- Have no medical contraindications determined by the following: an adequate medical history, a physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, and urinalysis.
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- Have a negative drug test for barbiturates, benzodiazepines, opiates, cocaine, amphetamines and ethanol at the time of hospital admission (Day 0).
- Are females who have a negative pregnancy test at hospital admission.
- Are of either non-childbearing (tubal ligation or total hysterectomy) or of childbearing potential using one or more of the following barrier methods of contraception: male or female condoms (with/without spermicide), diaphragm (with spermicide) and/or copper containing intrauterine device (with/without spermicide). No other contraceptives are acceptable.
Who cannot join
- Please contact 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: Phase 1 Study of Interactions Between Oral Naltrexone and Bupropion and Intravenous Methamphetamine in Methamphetamine Experienced Volunteers
The study is to primarily measure safety and interactions between oral doses of Naltrexone/Bupropion and i.v. Methamphetamine.
- Conditions
- Methamphetamine Dependence
- Being tested
- placebo, Naltrexone and Bupropion SR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboOther
matching placebo
Naltrexone and Bupropion SRDrug
25mg bid/day (NX) 200mg bid/day (BUP)
| Study group | Role | What they receive |
|---|---|---|
| Naltrexone and Bupropion SR | Active comparator | Not described Receives: Drug: Naltrexone and Bupropion SR |
| Placebo | Placebo comparator | Not described Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular System Effects
Heart rate, blood pressure, ECGs,and monitoring adverse events
Measured: daily during the 10 day treatment period
Number of subjects with adverse events
Measured: Day 0 through Day 10
Secondary outcomes (3)
Plasma concentrations obtained at specific timepoints
- PK of IV (meth) and its metabolites before and during Naltrexone/BUP exposure
- PK of bupropion, naltrexone and their metabolites
Measured: daily during the 10 day treatment period
Assessment of Vital Signs and Clinical Chemistries
Respiration rate and clinical laboratory measures
Measured: Daily during the 10 day treatment period
Cognitive Assessments as reported by the subject
Subject reported effects measured with VAS, BSCS, and POMS
Measured: Dailly during the 10 day treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2011 (estimated)
- Study startAug 2011
- Primary completionJun 2012
- Study completionJun 2012
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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01359930
- Sponsor's protocol ID
- NaltrexoneBupropion-Ph1A-met
- Status last verified
- Jul 2013
- First submitted
- 18 May 2011
- Last updated
- 12 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Interactions Between Oral Naltrexone and Bupropion and Intravenous Methamphetamine in Methamphetamine Experienced Volunteers
- ClinicalTrials.gov ID
- NCT01359930
- Acronym / sponsor ID
- NaltrexoneBupropion-Ph1A-met
- Conditions
- Methamphetamine Dependence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Aug 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 25 May 2011 (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 study is to primarily measure safety and interactions between oral doses of Naltrexone/Bupropion and i.v. Methamphetamine.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naltrexone and Bupropion SR | Active comparator | Drug: Naltrexone and Bupropion SR |
| Placebo | Placebo comparator | Other: placebo |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Are MA experienced but not dependent, males or females aged 21-to-50 years.
- Reported use of MA during the past six months without experiencing an adverse consequence plus a life time MA or amphetamine use history of at least four occasions of use.
- Have a body mass index (BMI) between 18 and 30.
- Are willing and able to give written consent.
- Are not currently a subject (including still in the follow-up period) of another drug research study.
Key exclusion criteria (1 listed)
- Please contact 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 |
|---|---|---|
| placebomatching placebo | Other | Placebo |
| Naltrexone and Bupropion SR25mg bid/day (NX) 200mg bid/day (BUP) | Drug | Naltrexone and Bupropion SR |
Primary outcome
Cardiovascular System Effects
Time frame: daily during the 10 day treatment period
Heart rate, blood pressure, ECGs,and monitoring adverse events
Number of subjects with adverse events
Time frame: Day 0 through Day 10
3 secondary outcomes
Plasma concentrations obtained at specific timepoints
Time frame: daily during the 10 day treatment period
Assessment of Vital Signs and Clinical Chemistries
Time frame: Daily during the 10 day treatment period
Cognitive Assessments as reported by the subject
Time frame: Dailly during the 10 day treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Naltrexone and Bupropion SR 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 9 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: finished, as of the sponsor's last update on 12 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cardiovascular System Effects (time frame: daily during the 10 day treatment period). 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?
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 12 Jan 2017.