Minocycline and Tobacco Craving in Smokers With Schizophrenia
Condition: Schizophrenia; Tobacco Use
MeSH terms: Schizophrenia
Intervention: Minocycline; Placebo
Intervention description: Minocycline capsules taken twice daily for two weeks.; Placebo capsules taken twice daily for two weeks.
Intervention MeSH terms: Minocycline
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Craving for cigarettes is an important aspect that leads to challenges with smoking
      cessation. Persons with schizophrenia are more likely to smoke and to be heavier smokers than
      persons without schizophrenia, and may experience craving differently as well. Minocycline is
      an antibiotic medication that may impact craving. We will conduct a two-week randomized,
      double-blind, placebo-controlled, parallel group pilot study to investigate the effects of
      minocycline vs. placebo on craving and smoking behaviors in smokers with schizophrenia.
      Participants will take minocycline or matching placebo for two weeks. Participants will be
      assessed on aspects of craving and smoking behavior at baseline and after 1 and 2 weeks of
      minocycline or placebo treatment.
    

Eligibility criteria:

        Inclusion Criteria

          -  DSM-IV or DSM-5 diagnosis of schizophrenia or schizoaffective disorder

          -  Male or Female

          -  Age: 18 to 65 years

          -  Caucasian or Non-Caucasian

          -  Smoke at least 10 cigarettes daily

          -  Urine cotinine level ≥ 100 ng/ml (NicAlert® reading ≥ 3)

          -  Agrees to wear a head mounted display (HMD) for up to 45 minutes

          -  Able to complete the Evaluation to Sign Consent (ESC) with minimum score of 80%

        Exclusion Criteria

          -  History of organic brain disease

          -  DSM-IV diagnosis of Alcohol or Substance Dependence within the last six months (except
             nicotine) or DSM-5 diagnosis of Substance Use Disorder in the last six months (except
             nicotine)

          -  DSM-IV diagnosis of Alcohol or Substance Abuse within the last one month (except
             nicotine) or DSM-5 diagnosis of Substance Use Disorder in the last six months (except
             nicotine)

          -  Pregnancy or lactation

          -  Severe liver dysfunction (LFT 3X upper limit of normal)

          -  Previous known hypersensitivity to tetracyclines

          -  Current treatment with tetracycline or derivative

          -  Treatment with oral contraceptives (unless a second form of birth control is used and
             documented)

          -  Treatment with cholestyramine or colestipol

          -  Treatment with Urinary alkalinizers (e.g., sodium lactate, potassium citrate)

          -  Treatment with warfarin

          -  Treatment with bupropion, varenicline, or nicotine replacement products in the month
             prior to study inclusion

          -  Less than two months treatment of adjunctive medications AND less than one month on
             same dose: beta blockers, antidepressants, mood stabilizers, antianxiety medications.

          -  Medical condition whose pathology or treatment would significantly increase the risk
             associated with the proposed protocol.

          -  History of head injury, seizures, or stroke

          -  Positive urine toxicology screen for substances of non-therapeutic use prior to
             craving assessments