Pilot Trial of Bupropion Versus Placebo for Methamphetamine Abuse in Adolescents

Official Title: “Pilot Trial of Bupropion Versus Placebo for Methamphetamine Abuse in Adolescents”

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.

Intervention(s) in this Clinical Trial

• Drug: Bupropion SR 150mg tabs
  • Bupropion SR 150mg tabs (Zyban) twice daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Bupropion
• Placebo Comparator: Placebo (sugar pill)

Primary Measures

• feasibility of retaining adolescents in trial
  • Time Frame: 8 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• 1. age 14 years to 21 years of age, inclusive;
• 2. meet DSM-IV criteria for methamphetamine abuse or dependence as determined by the K-SADS-PL;
• 3. seeking treatment for MA problems;
• 4. report MA use on 18 or fewer of the past 30 days at baseline;
• 5. willing and able to comply with study procedures;
• 6. 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 7. able to complete study assessments in English due to the lack of some measures in Spanish;
• 8. if female, not pregnant or lactating and willing to use an acceptable method of barrier birth control (e.g. condoms) during the trial.

Exclusion Criteria:

• 1. 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);
• 2. 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;
• 3. currently taking bupropion for depression, smoking cessation or OCD within 30 days of baseline;
• 4. taking any prescription medication for ADHD;
• 5. currently on prescription medication that is contraindicated for use with bupropion;
• 6. have current dependence on cocaine, opiates, alcohol, or benzodiazepines as defined by DSM-IV-TR;
• 7. have a self-reported history of a seizure disorder or serious closed head injury;
• 8. 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;
• 9. have a current or past history of anorexia or bulimia;
• 10. body weight less than 50kgs;
• 11. have current hypertension uncontrolled by medication;
• 12. have a history of sensitivity to bupropion; and 13. any other circumstances that, in the opinion of the investigators, would compromise participant safety.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 14 Years

Maximum Age for this Clinical Trial: 21 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: University of California, Los Angeles Other

Overall Clinical Trial Officials and Contacts

Keith Heinzerling, MD, MPH Principal Investigator UCLA Department of Family Medicine  

Overall Contact: Janette Gadzhyan 323-804-9305 JGadzhyan@mednet.ucla.edu

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00994448

Study ID Number: 1R21DA026513

ClinicalTrials.gov Identifier: NCT00994448

Health Authority: United States: Food and Drug Administration