Minocycline and Tobacco Craving in Smokers With Schizophrenia
| Status: | Recruiting |
|---|---|
| Conditions: | Schizophrenia, Smoking Cessation |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 5/6/2018 |
| Start Date: | March 31, 2017 |
| End Date: | April 2020 |
| Contact: | Heidi J Wehring, PharmD, BCPP |
| Email: | hwehring@mprc.umaryland.edu |
| Phone: | 410-402-6842 |
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.
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.
Nicotine dependence is high in schizophrenia; nearly three times more prevalent than the
general population. In smokers with schizophrenia, the risk of all-cause mortality is doubled
and cardiovascular mortality risk is twelvefold higher than nonsmokers. Many factors
influence smoking in persons with schizophrenia, but predictors of craving and smoking
behavior are not well established. Craving is a major contributor to smoking behaviors, and,
importantly, is a predictor of relapse risk. Since craving may precede relapse, it can be
advantageous as a screening tool for those attempting cessation. In addition, focusing on
treatments aimed to reduce craving may lead to better therapeutic targets. Minocycline may
affect craving, perhaps due to inhibition of nitric oxide (NO) formation, as NO acts as a
second messenger for glutamate and dopamine receptors. NO also facilitates the effects of
nicotine in the reward circuit, and blockade of NO has been demonstrated to eliminate
nicotine abstinence symptoms in rats. A small study has demonstrated that minocycline reduces
cigarette craving in human subjects without severe mental illness. The investigators 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 indicators of smoking
intensity in smokers with schizophrenia. Participants will take minocycline up to 200 mg
daily or matching placebo for two weeks. Participants will complete cigarette cue-elicited
craving platforms and related assessments at baseline, and after 1 and 2 weeks of minocycline
or placebo treatment.
general population. In smokers with schizophrenia, the risk of all-cause mortality is doubled
and cardiovascular mortality risk is twelvefold higher than nonsmokers. Many factors
influence smoking in persons with schizophrenia, but predictors of craving and smoking
behavior are not well established. Craving is a major contributor to smoking behaviors, and,
importantly, is a predictor of relapse risk. Since craving may precede relapse, it can be
advantageous as a screening tool for those attempting cessation. In addition, focusing on
treatments aimed to reduce craving may lead to better therapeutic targets. Minocycline may
affect craving, perhaps due to inhibition of nitric oxide (NO) formation, as NO acts as a
second messenger for glutamate and dopamine receptors. NO also facilitates the effects of
nicotine in the reward circuit, and blockade of NO has been demonstrated to eliminate
nicotine abstinence symptoms in rats. A small study has demonstrated that minocycline reduces
cigarette craving in human subjects without severe mental illness. The investigators 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 indicators of smoking
intensity in smokers with schizophrenia. Participants will take minocycline up to 200 mg
daily or matching placebo for two weeks. Participants will complete cigarette cue-elicited
craving platforms and related assessments at baseline, and after 1 and 2 weeks of minocycline
or placebo treatment.
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
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