Varenicline and Alcohol in Inpatient Addictions Program (IAP)

NCT01169610 | Terminated Phase 3 Results

• 1 other identifier: 10-002699
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The overall hypothesis of this line of research is that varenicline will decrease alcohol consumption and tobacco use and will increase alcohol and tobacco abstinence rates. In order to explore this hypothesis, the investigators will conduct a two-phase study: 1) an open label pilot study investigating the effect of varenicline on reduction of and abstinence from alcohol and tobacco; and 2) an optional MR spectroscopy to investigate whether glutamate and other brain metabolites correlate to measures of alcohol craving severity and/or subsequent varenicline treatment response.

Conditions

Alcoholism; Nicotine Dependence

Keywords

Alcohol; Smoking

Outcome Measures

Primary Outcomes (2)

• Continuous Alcohol Abstinence

  No consumption of alcohol (not even a single drink) during the specified interval of time. This will be a self-reported outcome.

  Two years

• Heavy Drinking Days

  Number of drinking days \> 5 drinks/day for men and \> 4 drink/day for women. This will be a self-reported outcome.

  Two years

Secondary Outcomes (3)

• 7-day Point Prevalence Smoking Abstinence

  Two years

• Prolonged Smoking Abstinence

  Two years

• Tolerability of Varenicline

  Two years

Study Arms (1)

Varenicline

EXPERIMENTAL

Drug: Varenicline

Interventions

Varenicline DRUG

Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.

Also known as: Chantix

Varenicline

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Subjects will be eligible for enrollment if they: 1. Are \> 18 and \< 70 years of age 2. Are admitted to the inpatient addiction program (IAP) in the Generose Building at Saint Marys Hospital 3. Have been diagnosed with alcohol dependence based on DSM-IV-TR criteria and confirmed by Psychiatric Research Interview for Substance and Mental Disorders (PRISM) 4. Smoke at least 10 cigarettes/day for ≥ 6 months 5. Are able to participate fully in all aspects of the study 6. Have been provided with, understand, and have signed the informed consent; and 7. Agree to identify collateral individuals for contact purposes to facilitate follow-up appointments. Patients will be excluded from participation if they: 1. Meet DSM-IV criteria of schizophrenia or other non-affective psychotic disorder 2. Have had psychotic symptoms within the past month 3. Have an Axis I disorder requiring new pharmacotherapy 4. Have a predominant Axis II disorder 5. Have used an investigational drug within 30 days of enrollment 6. Have started Naltrexone or Acamprosate during this same IAP admission 7. Have a history (past 3 months) of drug abuse (excluding caffeine and marijuana) 8. Have active suicidality as measured by screening questions from the Columbia-Suicide Severity Rating Scale (C-SSRS), (Posner 2008) outlined below: a. "Yes" response to questions 1, 2, or 3 with significant intensity level endorsed as: i. Frequency: score of 4 or 5 ii. Duration: score of 3, 4 or 5 iii. Controllability: score of 0, 4, or 5 iv. Deterrents: score of 0, 4 or 5 v. Reasons for Ideation: score of 1, 2, 3, 4 or 5 b. "Yes" response to question 4 c. "Yes" response to question 5 9. Have a history of medically serious suicide attempt within 5 years 10. Have a history of any major cardiovascular events including arrhythmias, congestive heart failure, unstable angina, acute MI or coronary angioplasty 11. Are pregnant, lactating, or of child bearing potential, likely to become pregnant during the medication phase and not willing to use a reliable form of contraception. Reliable forms of contraception include diaphragm or condom (with spermicidal), injections, intrauterine device \[IUD\], surgical sterilization and abstinence; 12. Have clinically significant acute or chronic progressive or unstable neurologic, hepatic, renal, cardiovascular, respiratory or metabolic disease 13. Have another household member or relative participating in the study 14. Have a known allergy to varenicline 15. Are individuals, in the investigators opinion, unable to comply with study procedures 16. Are unable to provide written informed consent in English 17. Are on hemodialysis or have a history of kidney disease. Patients will be excluded from participation in the MR spectroscopy portion of the study if they have: 1. Claustrophobia 2. A history of major head trauma with loss of consciousness \> 5 minutes or skull fracture 3. A history of previous neurological event (e.g., epilepsy, stroke, transient ischemic attack) 4. Implanted metal objects (e.g., pacemakers; aneurysm clips; metal prostheses, joints, rods, or plates) 5. Contraindication to MRI scanning.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Alcoholism; Tobacco Use Disorder; Smoking

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Results Point of Contact

• Title: Mark A. Frye, MD
• Organization: Mayo Clinic

mfrye@mayo.edu

507-255-9391

Study Officials

• Mark Frye, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: July 22, 2010
• First Posted: July 26, 2010
• Study Start: January 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: March 20, 2019
• Results First Posted: September 26, 2013

Record last verified: 2019-03

Locations

US (1)