Clinical Trials Logo

Clinical Trial Summary

This is a clinical research protocol to study the efficacy of combined varenicline (Chantix) and motivational interviewing (MI) for smoking cessation in a sample of smokers who have been diagnosed with schizophrenia or schizoaffective disorder. The study is a double-blind, randomized, controlled, subacute treatment trial of MI plus varenicline (VAR-MI) versus MI plus placebo (PLA-MI). The pharmaceutical treatment will utilize Chantix at a dose of 1 mg/day for a period of two weeks.

The primary goal is to determine if VAR-MI decreases baseline behavioral measures of urge and withdrawal and reduces baseline rates of cigarette consumption. The primary efficacy measures of VAR-MI vs. PLA-MI treatment are: Minnesota Nicotine Withdrawal Scale, Questionnaire for Smoking Urge-brief, number of cigarettes smoked per day in the previous week, CO levels, and Brief Psychiatric Rating Scale and Positive And Negative Symptom Scale scores on the last day of the study. Other primary outcome measures are to determine the effects of VAR-MI and PLA-MI on smoking cue-induced urges in tobacco cue reactivity sessions and reward responsiveness as assessed by a computerized task.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00781755
Study type Interventional
Source VA Boston Healthcare System
Contact
Status Withdrawn
Phase Phase 4

See also
  Status Clinical Trial Phase
Withdrawn NCT02432066 - Effects of GTS-21 on Smoking Behavior and Neurocognitive Functions Phase 2
Completed NCT03960138 - Examining the Effects of Neural Stimulation on Inhibitory Control and Cigarette Smoking N/A
Recruiting NCT05030272 - Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings N/A
Completed NCT04646668 - Comparative Abuse Liability Among African American and White Smokers N/A
Completed NCT02560324 - Effect of Ramelteon on Smoking Abstinence Phase 2
Completed NCT02347605 - Medicinal Nicotine for Preventing Cue Induced Craving N/A
Completed NCT01428310 - Study to Evaluate the Safety and Efficacy of Dietary Supplement Anatabloc in Reducing Daily Smokers' Urge to Smoke Phase 1
Terminated NCT01800500 - Interest in Smokeless Tobacco Product as a Substitution for Cigarettes in Current Smokers N/A
Completed NCT01570595 - Positively Smoke Free on the Web (PSFW) for Smokers Living With HIV Phase 1/Phase 2
Completed NCT01442753 - Family-Skills Training to Prevent Tobacco and Other Substance Use in Latino Youth N/A
Completed NCT01625767 - Tobacco Approach Avoidance Training for Adolescent Smokers-1 Phase 2
Active, not recruiting NCT01539525 - Screening to Augment Referral to Treatment- Project START Phase 2
Completed NCT00967005 - N-Acetyl Cysteine Plus Behavioral Therapy for Nicotine Dependent Pathological Gamblers Phase 2
Completed NCT01337817 - A Pilot Study to Evaluate the Efficacy and Safety of Ariva® Silver Wintergreen in Healthy Smokers Phase 1
Active, not recruiting NCT00751660 - Screening Methods in Finding Lung Cancer Early in Current or Former Smokers N/A
Completed NCT00790569 - Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking N/A
Completed NCT00664261 - Clinical Effort Against Secondhand Smoke (CEASE) Program or Standard Care in Helping Parents Stop Smoking N/A
Completed NCT00134927 - A Survey on Consumer Use of Over-the-Counter (OTC) Nicotine Patches N/A
Completed NCT00218179 - Assessing the Link Between Smoke Carcinogen Biomarkers and Lung Cancer Risk - 1 N/A
Completed NCT00158158 - Effectiveness of Reducing Smoking in Facilitating Smoking Cessation in Adolescents - 2 Phase 2/Phase 3