Varenicline vs Placebo for the Treatment of Methamphetamine Dependence
Condition: Methamphetamine Dependence; Substance Abuse; Methamphetamine Abuse
MeSH terms: Substance-Related Disorders
Intervention: Varenicline; Placebo
Intervention description: Varenicline dosing will follow that which has been shown to be effective for cigarette smoking cessation. Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 8).; Placebo dose will start at 0.5 mg (sugar pill) daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 8).
Intervention MeSH terms: Varenicline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: methamphetamine; crystal meth; addiction; los angeles; medication; meth

Summary:

      Methamphetamine (MA) abuse is the fastest growing drug problem in the United States and is
      responsible for significant public health complications, including HIV infection. As a result
      effective treatments for MA dependence are urgently needed. There are currently no
      efficacious medications for MA dependence, although results from preliminary randomized
      trials of bupropion for MA dependence found bupropion to be more effective than placebo, but
      only among subgroups of participants, including those with lower frequency of MA use at
      baseline. A growing body of preclinical and clinical studies suggest that cholinergic
      mechanisms play an important role in the neurobiology of MA and other stimulant dependence,
      such as nicotine dependence. Mechanistically, cholinergic medications may alleviate
      MA-associated cognitive dysfunction, thereby improving outcomes of treatment for MA
      dependence. Varenicline is a partial agonist at α4β2 nicotinic receptors and a full agonist
      at α7 nicotinic receptors that has been approved as an anti-cigarette smoking medication. In
      order to assess the potential efficacy of varenicline for methamphetamine dependence, we will
      perform a clinical trial to assess if varenicline compared to placebo results in greater:

        1. reductions in methamphetamine use;

        2. treatment retention;
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 years of age or older;

          2. meet (Diagnostic and Statistical Manual of Mental Disorders) DSM-IV criteria for
             methamphetamine (MA) dependence;

          3. seeking treatment for MA problems;

          4. willing and able to comply with study procedures;

          5. willing and able to provide written informed consent;

          6. 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 tuberculosis, unstable cardiac, renal, or liver
             disease, uncontrolled hypertension, unstable diabetes);

          2. have a current neurological disorder (e.g., organic brain disease, dementia) or a
             medical history which would make study agent compliance difficult or which would
             compromise informed consent;

          3. have a current major psychiatric disorder not due to substance abuse (e.g.,
             schizophrenia, bipolar disorder) as assessed by the Structured Clinical Interview for
             DSM Disorders (SCID);

          4. have a history of attempted suicide in the past 3 years and/or serious suicidal
             intention or plan in the past year as assessed by the Columbia Suicide Severity Rating
             Scale (C-SSRS);

          5. currently on prescription medication that is contraindicated for use with varenicline;

          6. currently using any form of nicotine replacement therapy, due to potential
             interactions with varenicline;

          7. have current dependence on cocaine, opiates, alcohol, or benzodiazepines as defined by
             DSM-IV;

          8. have a history of alcohol dependence within the past three years;

          9. have a history of sensitivity to varenicline or any other circumstances that, in the
             opinion of the investigators, would compromise participant safety.