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| Sponsor: | University of California, Los Angeles |
|---|---|
| Collaborators: |
National Institute on Drug Abuse (NIDA) Behavioral Health Services, Inc. |
| Information provided by: | University of California, Los Angeles |
| ClinicalTrials.gov Identifier: | NCT00994448 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Adolescent Methamphetamine Abuse |
Drug: Bupropion SR 150mg tabs |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Pilot Trial of Bupropion Versus Placebo for Methamphetamine Abuse in Adolescents |
| Estimated Enrollment: | 30 |
| Study Start Date: | October 2009 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Bupropion: Experimental |
Drug: Bupropion SR 150mg tabs
Bupropion SR 150mg tabs (Zyban) twice daily
|
| Placebo (sugar pill): Placebo Comparator |
Drug: Bupropion SR 150mg tabs
Bupropion SR 150mg tabs (Zyban) twice daily
|
Eligibility| Ages Eligible for Study: | 14 Years to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Janette Gadzhyan | 323-461-3106 | JGadzhyan@mednet.ucla.edu |
| United States, California | |
| Behavioral Health Services- Lincoln Heights Family Recovery Center | Recruiting |
| Los Angeles, California, United States, 90032 | |
| Contact: Janette Gadzhyan 323-461-3106 JGadzhyan@mednet.ucla.edu | |
| Principal Investigator: | Keith Heinzerling, MD, MPH | UCLA Department of Family Medicine |
More Information
| Responsible Party: | UCLA Department of Family Medicine ( Keith Heinzerling, MD, MPH ) |
| Study ID Numbers: | 1R21DA026513 |
| Study First Received: | October 13, 2009 |
| Last Updated: | October 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00994448 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Adolescents Methamphetamine abuse Bupropion Addiction |
Pharmacotherapy Cognitive Behavioral Therapy Contingency Management Teens |
|
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Adrenergic Uptake Inhibitors Sympathomimetics Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Stimulants Pharmacologic Actions |
Methamphetamine Autonomic Agents Therapeutic Uses Bupropion Amphetamine Dopamine Agents Peripheral Nervous System Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |