Study of Medical Treatment for Methamphetamine Addiction
Condition: Methamphetamine; Amphetamine Dependence; Pharmacogenetics; Methamphetamine Dependence; Substance Abuse
MeSH terms: Substance-Related Disorders; Amphetamine-Related Disorders
Intervention: Bupropion
Intervention description: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
Intervention MeSH terms: Bupropion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Methamphetamine; Addiction; Pharmacogenomics; Amphetamine; Bupropion; Meth; Crank; Crystal

Summary:

      Currently there are no medications approved for the treatment of methamphetamine addiction.
      Bupropion is an antidepressant that is approved by the Food and Drug Administration (FDA) for
      the treatment of depression and for cigarette smoking cessation but is not approved by the
      FDA for the treatment of methamphetamine addiction. Preliminary research studies suggest that
      bupropion may help people receiving treatment for methamphetamine addiction to reduce or to
      stop their methamphetamine use. But results of these studies also suggest that bupropion may
      help certain groups of patients more than others, such as men versus women and light versus
      heavy methamphetamine users, although the reasons for this difference are not known. One
      possibility is that a person's genetic make up may influence whether or not they respond to
      treatment with bupropion for methamphetamine addiction.

      The purpose of the study is to determine if bupropion is can help people reduce or stop their
      methamphetamine use and to investigate whether genetic variations influence whether people
      respond to treatment with bupropion for methamphetamine addiction, which may help doctors and
      patients better decide if treatment with bupropion will be beneficial or not. To identify
      possible genetic variations that influence response to bupropion, we will perform genetic
      tests on blood or saliva specimens from participants receiving treatment with either
      bupropion or placebo (which is a pill that contains no medication) in conjunction with
      standard cognitive behavioral therapy drug counseling. We will compare methamphetamine use,
      as assessed with urine drug screens, among participants receiving bupropion versus those
      receiving placebo to determine if bupropion helps people to reduce or stop their
      methamphetamine use. We will then compare the results of the genetic tests among participants
      who respond and who do not respond to bupropion. In addition, since the amount of
      methamphetamine a person uses was associated with response to bupropion in preliminary
      studies, we will also compare the results of genetic testing among persons with heavy versus
      light methamphetamine use before entering treatment.

      Results of this study have the potential to provide insights into the biology of
      methamphetamine addiction and help increase the understanding of how bupropion works. This
      information could be useful to develop effective medications for methamphetamine addiction
      and to improve the ability of clinicians to provide treatment to patients with
      methamphetamine addiction.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 years of age or older;

          2. meet DSM-IV criteria for methamphetamine dependence;

          3. seeking treatment for MA problems;

          4. specific range of methamphetamine use in the 30 days prior to study entry;

          5. willing and able to comply with study procedures, including genotyping;

          6. willing and able to provide written informed consent;

          7. 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 SCID or a medical history which would make study agent
             compliance difficult or which would compromise informed consent, or recent (past 30
             days) history of suicide attempts and/or current serious suicidal intention or plan as
             assessed by the SCID;

          3. currently on prescription medication that is contraindicated for use with bupropion;

          4. have current dependence on cocaine, opiates, alcohol, or benzodiazepines as defined by
             DSM-IV-TR;

          5. have a history of alcohol dependence within the past three years;

          6. have a history of a seizure disorder;

          7. 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;

          8. have a history of anorexia or bulimia;

          9. have current hypertension uncontrolled by medication, or any other circumstances that,
             in the opinion of the investigators, would compromise participant safety;

         10. have a history of sensitivity to bupropion.