Adolescent Methamphetamine AbusePhase 2NCT00994448
Pilot Trial of Bupropion Versus Placebo for Methamphetamine Abuse in Adolescents
A Phase 2 study testing Bupropion SR 150mg tabs in people with Adolescent Methamphetamine Abuse, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Dr Keith Heinzerling, who is a doctor at UCLA, is doing a research study with Behavioral Health Services in the Lincoln Heights neighborhood of Los Angeles to find out if a medication called bupropion can help adolescents (age 14-21) reduce or stop using methamphetamine. Read more about this study
- Who is it for?
- Ages 14 to 21 years
- Conditions the study is for
- Adolescent Methamphetamine Abuse
- What is being tested?
- Bupropion SR 150mg tabs
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Dec 2011
- Phase
- Phase 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 14 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age 14 years to 21 years of age, inclusive;
- meet DSM-IV criteria for methamphetamine abuse or dependence as determined by the K-SADS-PL;
- seeking treatment for MA problems;
- report MA use on 18 or fewer of the past 30 days at baseline;
- willing and able to comply with study procedures;
- willing and able to provide informed assent (for youth <18 yr) or consent (for youth ≥18 yr) and parents willing to provide informed consent (for youth <18) to participate in the project; and
- able to complete study assessments in English due to the lack of some measures in Spanish;
- if female, not pregnant or lactating and willing to use an acceptable method of barrier birth control (e.g. condoms) during the trial.
Who cannot join
- have a medical condition that, in the study physician's judgment, may interfere with safe study participation (e.g., active TB, unstable cardiac, renal, or liver disease, unstable diabetes);
- have a current neurological disorder (e.g., organic brain disease, dementia) or major psychiatric disorder not due to substance abuse (e.g., schizophrenia, bipolar disorder) as assessed by the K-SADS-PL other than attention deficit-hyperactivity disorder (see below) or a medical history which would make study agent compliance difficult or which would compromise informed consent, or history of suicide attempts in the past year and/or current serious suicidal intention or plan as assessed by the K-SADS-PL;
- currently taking bupropion for depression, smoking cessation or OCD within 30 days of baseline;
- taking any prescription medication for ADHD;
- currently on prescription medication that is contraindicated for use with bupropion;
- have current dependence on cocaine, opiates, alcohol, or benzodiazepines as defined by DSM-IV-TR;
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- have a self-reported history of a seizure disorder or serious closed head injury;
- have a medical condition (such as serious head injury) that is associated with increased risk of seizures or on a medication that lowers the seizure threshold;
- have a current or past history of anorexia or bulimia;
- body weight less than 50kgs;
- have current hypertension uncontrolled by medication;
- have a history of sensitivity to bupropion; and
- any other circumstances that, in the opinion of the investigators, would compromise participant safety.
Trial locations and contacts
1 site in 1 country.
United States1 site
Behavioral Health Services- Lincoln Heights Family Recovery Center
Los Angeles, California, 90032
About this study
Dr Keith Heinzerling, who is a doctor at UCLA, is doing a research study with Behavioral Health Services in the Lincoln Heights neighborhood of Los Angeles to find out if a medication called bupropion can help adolescents (age 14-21) reduce or stop using methamphetamine. Bupropion is a drug that is already on the market, which means it has been approved by the FDA, but it has not been approved to treat methamphetamine abuse. What the study is trying to find out is if bupropion helps people to stop using methamphetamine. The study lasts up to 14 weeks and involves visits to the BHS clinic in Lincoln Heights twice a week. The first two weeks involve completion of questionnaires and assessments, including a physical exam, a blood test, EKG (a test that checks for problems with the electrical activity of a person's heart), and a psychological interview, to see if you are eligible for the study. If you are eligible, then you will be assigned by chance to take either the bupropion pills or placebo pills, which are pills that look the same, but contain no medication. This type of study is called a "double blind study" because neither you nor any of the study staff will know which medication you are taking. During the 8 weeks of taking the pills, you'll visit the clinic to complete additional questionnaires and assessments, to provide urine samples for testing for methamphetamine, and for once a week drug abuse counseling. At the end of your treatment, you'll have another physical exam including blood tests and the same test on your heart and then we'll ask you to come to the clinic once a week for four weeks for follow-up assessments. You'll be compensated for time spent doing research activities and for returning empty medication packages. The total compensation possible is $332 in gift cards for places such as Target, iTunes, groceries, and gas.
Your participation in the study is voluntary and deciding not to participate or deciding to stop participating at any time during the study is okay.
- Conditions
- Adolescent Methamphetamine Abuse
- Being tested
- Bupropion SR 150mg tabs, Placebo tablets
- Keywords
- Adolescents, Methamphetamine abuse, Bupropion, Addiction, Pharmacotherapy, Cognitive Behavioral Therapy, Contingency Management, Teens
- Medical subject headings
- Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupropion SR 150mg tabsDrug
Bupropion SR 150mg tabs (Zyban) twice daily
Placebo tabletsDrug
One placebo tablet twice daily
| Study group | Role | What they receive |
|---|---|---|
| Bupropion | Experimental | Not described Receives: Drug: Bupropion SR 150mg tabs |
| Placebo (sugar pill) | Placebo comparator | Not described Receives: Drug: Placebo tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Retaining Adolescents in Trial
the mean retention for participants is used to assess feasibility of retaining adolescents in the trial (completion = 56 days or 8 weeks)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionDec 2011
- Study completionDec 2011
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 Adolescent 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 19 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), Behavioral Health Services, Inc.
- Responsible party
- Principal investigator, Keith Heinzerling, University of California, Los Angeles
- Investigators
- Keith Heinzerling, MD, MPH, Principal investigator, UCLA Department of Family Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00994448
- Sponsor's protocol ID
- 1R21DA026513
- Status last verified
- Feb 2013
- First submitted
- 13 Oct 2009
- Last updated
- 4 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Bupropion Versus Placebo for Methamphetamine Abuse in Adolescents
- ClinicalTrials.gov ID
- NCT00994448
- Acronym / sponsor ID
- 1R21DA026513
- Conditions
- Adolescent Methamphetamine Abuse
- Keywords
- Adolescents, Methamphetamine abuse, Bupropion, Addiction, Pharmacotherapy, Cognitive Behavioral Therapy, Contingency Management, Teens
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Behavioral Health Services, Inc.
- Study start
- Oct 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 14 Oct 2009 (estimated)
- Results
- Posted 4 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dr Keith Heinzerling, who is a doctor at UCLA, is doing a research study with Behavioral Health Services in the Lincoln Heights neighborhood of Los Angeles to find out if a medication called bupropion can help adolescents (age 14-21) reduce or stop using methamphetamine. Bupropion is a drug that is already on the market, which means it has been approved by the FDA, but it has not been approved to treat methamphetamine abuse. What the study is trying to find out is if bupropion helps people to stop using methamphetamine. The study lasts up to 14 weeks and involves visits to the BHS clinic in Lincoln Heights twice a week. The first two weeks involve completion of questionnaires and assessments, including a physical exam, a blood test, EKG (a test that checks for problems with the electrical activity of a person's heart), and a psychological interview, to see if you are eligible for the study. If you are eligible, then you will be assigned by chance to take either the bupropion pills or placebo pills, which are pills that look the same, but contain no medication. This type of study is called a "double blind study" because neither you nor any of the study staff will know which medication you are taking. During the 8 weeks of taking the pills, you'll visit the clinic to complete additional questionnaires and assessments, to provide urine samples for testing for methamphetamine, and for once a week drug abuse counseling. At the end of your treatment, you'll have another physical exam including blood tests and the same test on your heart and then we'll ask you to come to the clinic once a week for four weeks for follow-up assessments. You'll be compensated for time spent doing research activities and for returning empty medication packages. The total compensation possible is $332 in gift cards for places such as Target, iTunes, groceries, and gas.
Your participation in the study is voluntary and deciding not to participate or deciding to stop participating at any time during the study is okay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupropion | Experimental | Drug: Bupropion SR 150mg tabs |
| Placebo (sugar pill) | Placebo comparator | Drug: Placebo tablets |
Who may qualify
- Ages
- 14 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- age 14 years to 21 years of age, inclusive;
- meet DSM-IV criteria for methamphetamine abuse or dependence as determined by the K-SADS-PL;
- seeking treatment for MA problems;
- report MA use on 18 or fewer of the past 30 days at baseline;
- willing and able to comply with study procedures;
Key exclusion criteria (13 listed)
- have a medical condition that, in the study physician's judgment, may interfere with safe study participation (e.g., active TB, unstable cardiac, renal, or liver disease, unstable diabetes);
- have a current neurological disorder (e.g., organic brain disease, dementia) or major psychiatric disorder not due to substance abuse (e.g., schizophrenia, bipolar disorder) as assessed by the K-SADS-PL other than attention deficit-hyperactivity disorder (see below) or a medical history which would make study agent compliance difficult or which would compromise informed consent, or history of suicide attempts in the past year and/or current serious suicidal intention or plan as assessed by the K-SADS-PL;
- currently taking bupropion for depression, smoking cessation or OCD within 30 days of baseline;
- taking any prescription medication for ADHD;
- currently on prescription medication that is contraindicated for use with bupropion;
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 |
|---|---|---|
| Bupropion SR 150mg tabsBupropion SR 150mg tabs (Zyban) twice daily | Drug | Bupropion |
| Placebo tabletsOne placebo tablet twice daily | Drug | Placebo (sugar pill) |
Primary outcome
Feasibility of Retaining Adolescents in Trial
Time frame: 8 weeks
the mean retention for participants is used to assess feasibility of retaining adolescents in the trial (completion = 56 days or 8 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Keith Heinzerling, MD, MPH principal investigator
UCLA Department of Family Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bupropion SR 150mg tabs in people with Adolescent Methamphetamine Abuse, 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 8 inclusion and 13 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 4 Apr 2013. 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 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 4 Apr 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?
Feasibility of Retaining Adolescents in Trial (time frame: 8 weeks). 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 4 Apr 2013.