Pilot Trial of Bupropion Versus Placebo for Methamphetamine Abuse in Adolescents

This study has been completed.
Sponsor:
Collaborators:
Behavioral Health Services, Inc.
Information provided by (Responsible Party):
Keith Heinzerling, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00994448
First received: October 13, 2009
Last updated: February 25, 2013
Last verified: February 2013
  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
Drug: Placebo tablets
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Trial of Bupropion Versus Placebo for Methamphetamine Abuse in Adolescents

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Feasibility of Retaining Adolescents in Trial [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    the mean retention for participants is used to assess feasibility of retaining adolescents in the trial (completion = 56 days or 8 weeks)


Enrollment: 19
Study Start Date: October 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   14 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00994448

Locations
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
Behavioral Health Services, Inc.
Investigators
Principal Investigator: Keith Heinzerling, MD, MPH UCLA Department of Family Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Keith Heinzerling, Assistant Clinical Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00994448     History of Changes
Other Study ID Numbers: 1R21DA026513
Study First Received: October 13, 2009
Results First Received: January 14, 2013
Last Updated: February 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, Los Angeles:
Adolescents
Methamphetamine abuse
Bupropion
Addiction
Pharmacotherapy
Cognitive Behavioral Therapy
Contingency Management
Teens

Additional relevant MeSH terms:
Methamphetamine
Bupropion
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 27, 2014