Combining Varenicline and Naltrexone for Smoking Cessation
Condition: Nicotine Dependence; Alcohol Use Disorder
MeSH terms: Alcoholism; Tobacco Use Disorder
Intervention: Varenicline; Varenicline plus Naltrexone
Intervention description: Varenicline 1 mg twice daily; Varenicline 1 mg twice daily plus Naltrexone 50 mg once daily
Intervention MeSH terms: Naltrexone; Varenicline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 165.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study is a double-blind, randomized clinical trial using a two group medication design
      consisting of the combination of VAR (1 mg twice daily) + NTX (50 mg once daily) and VAR (1
      mg twice daily) + PLA (matched to NTX), for smoking cessation in a sample of heavy drinking
      daily smokers who want to quit smoking and reduce drinking.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Be treatment-seeking for smoking cessation and have a desire to reduce or quit
             drinking

          2. Be between the ages of 21 and 65

          3. Be able to provide informed consent

          4. Smoke 5 or more cigarettes per day for the past year

          5. Currently drink heavily according to the National Institute on Alcohol Abuse and
             Alcoholism (NIAAA) guidelines: for men, > 14 drinks per week or ≥ 5 drinks per
             occasion at least once per month over the past 12 months; for women, > 7 drinks per
             week or ≥ 4 drinks per occasion at least once per month over the past 12 months

          6. Pass the physical exam and associated laboratory tests, as determined by study
             physician

        Exclusion Criteria:

          1. Have clinically significant alcohol withdrawal, indicated by a score ≥ 10 on the
             Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) and assessed at the
             in-person screening visits

          2. Have lifetime DSM-V diagnosis of schizophrenia, bipolar disorder, a psychotic
             disorder, or any other psychiatric disorder as determined by the clinical interview

          3. Have major depressive disorder within the past year requiring treatment as determined
             by the clinical interview using DSM-V criteria

          4. Have a current or lifetime DSM-V diagnosis of a substance use disorder, other than for
             alcohol or nicotine, as determined by the clinical interview

          5. Have a prior history of taking FDA approved medications (i.e. varenicline or
             bupropion) for smoking cessation

          6. Be currently using any forms of nicotine replacement therapy (past use is acceptable)

          7. Be currently using tobacco products other than cigarettes (such as e-cigarettes,
             cigars, or chewing tobacco)

          8. Have a serious medical illness (significant cardiovascular disease; uncontrolled
             hypertension; hepatic or renal disease) that would contraindicate participation, as
             determined by the study physician

          9. Be currently taking insulin or oral hypoglycemic medication

         10. Be currently taking opioid pain medications or any form of opioid agonist maintenance
             therapy (such as methadone or buprenorphine)

         11. Be currently taking any other psychoactive medications; such as anti-depressants, mood
             stabilizers, anti-seizure medications, sedatives-hypnotics, anxiolytics, stimulants or
             antipsychotics

         12. Have self-reported use of cocaine, methamphetamine, heroin or other illicit drugs in
             the previous 60 days, verified by urine toxicology screen

         13. For women, must not be pregnant (as indicated by self-report or a positive pregnancy
             test at any study visit), nursing, or planning to become pregnant while taking part in
             the study, and must agree to a reliable method of birth control