Pilot Trial of Bupropion Versus Placebo for Methamphetamine Abuse in Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00994448
Recruitment Status : Completed
First Posted : October 14, 2009
Results First Posted : April 4, 2013
Last Update Posted : April 4, 2013
National Institute on Drug Abuse (NIDA)
Behavioral Health Services, Inc.
Information provided by (Responsible Party):
Keith Heinzerling, University of California, Los Angeles

Brief 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. 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 or disease Intervention/treatment Phase
Adolescent Methamphetamine Abuse Drug: Bupropion SR 150mg tabs Drug: Placebo tablets Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Trial of Bupropion Versus Placebo for Methamphetamine Abuse in Adolescents
Study Start Date : October 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Methamphetamine
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Bupropion Drug: Bupropion SR 150mg tabs
Bupropion SR 150mg tabs (Zyban) twice daily
Placebo Comparator: Placebo (sugar pill) Drug: Placebo tablets
One placebo tablet twice daily

Primary Outcome Measures :
  1. 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00994448

United States, California
Behavioral Health Services- Lincoln Heights Family Recovery Center
Los Angeles, California, United States, 90032
Sponsors and Collaborators
University of California, Los Angeles
National Institute on Drug Abuse (NIDA)
Behavioral Health Services, Inc.
Principal Investigator: Keith Heinzerling, MD, MPH UCLA Department of Family Medicine

Additional Information:
Responsible Party: Keith Heinzerling, Assistant Clinical Professor, University of California, Los Angeles Identifier: NCT00994448     History of Changes
Other Study ID Numbers: 1R21DA026513 ( U.S. NIH Grant/Contract )
First Posted: October 14, 2009    Key Record Dates
Results First Posted: April 4, 2013
Last Update Posted: April 4, 2013
Last Verified: February 2013

Keywords provided by Keith Heinzerling, University of California, Los Angeles:
Methamphetamine abuse
Cognitive Behavioral Therapy
Contingency Management

Additional relevant MeSH terms:
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Central Nervous System Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents
Adrenergic Uptake Inhibitors