Pilot Trial of Bupropion Versus Placebo for Methamphetamine Abuse in Adolescents
Condition: Adolescent Methamphetamine Abuse
Intervention: Bupropion SR 150mg tabs; Placebo tablets
Intervention description: Bupropion SR 150mg tabs (Zyban) twice daily; One placebo tablet twice daily
Intervention MeSH terms: Bupropion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 19.0
Sex: All
Minimum age: 14 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Adolescents; Methamphetamine abuse; Bupropion; Addiction; Pharmacotherapy; Cognitive Behavioral Therapy; Contingency Management; Teens

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.
    

Eligibility 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.