Phase 2
N=24
Varenicline and Smoking Cessation in Schizophrenia
Schizophrenia · Smoking Cessation
Bottom Line
View on ClinicalTrials.gov: NCT01111149 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcome: Primary: Smoking Abstinence - Serum/Urine Measurements — 198.67; 207; 213.8; 22.57 ng/mL — p=>0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sugar Pill (Other); Varenicline (Drug); Bupropion HCl (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Smoking Abstinence - Serum/Urine Measurements |
198.67; 207; 213.8; 22.57; 6; 15.4 | >0.05 |
| PRIMARY Smoking Abstinence - Number of Cigarettes Smoked |
19.71; 9.4; 17.1 | >0.05 |
| PRIMARY Smoking Abstinence - Exhaled Carbon Monoxide |
21.14; 17; 22.6 | >0.05 |
| SECONDARY Reduction in Smoking |
2; 2; 1; 2; 2; 1 | >0.05 |
| SECONDARY Negative Symptoms of Schizophrenia - SANS |
5.86; 17.2; 6.20; 1.71; 3.8; 1.6 | >0.05 |
| SECONDARY Impulsivity and Inattention |
5.62; 0.68; 2.42; 36.11; 25; 28.33 | >0.05 |
| SECONDARY Side Effects |
3; 3; 0; 0; 0; 1 | >0.05 |
| SECONDARY Abstinence-related Symptoms - MNWS and FTND |
4.86; 5.2; 4.4; 7.29; 8.2; 6.60 | >0.05 |
| SECONDARY Depression |
3.71; 8.6; 5.4 | >0.05 |
| SECONDARY Abnormal Movements - BAS and SAS |
0.2; 0.76; 0.42; 0.57; 0.6; 0.4 | >0.05 |
| SECONDARY Vital Signs |
116.29; 122; 128.4; 76.71; 78.4; 74.8 | >0.05 |
| SECONDARY Vital Signs - Weight |
218.39; 213.47; 254.78 | >0.05 |
| SECONDARY Vital Signs - Pulse |
82.57; 87; 89.2 | >0.05 |
| SECONDARY Suicidality |
1.71; 0.8; 0.4; 1.29; 1.2; 0.4 | >0.05 |
| SECONDARY Positive Symptoms of Schizophrenia (SAPS) |
3.43; 7; 10.6; 1.29; 1.2; 1.8 | >0.05 |
| SECONDARY General Psychopathology |
30; 34.2; 31.6; 8.14; 9; 8 | >0.05 |
| SECONDARY Hit Reaction Time - CPT |
42.44; 67.61; 63.81; 7.20; 6.96; 8.79 | >0.05 |
| SECONDARY Variability of Standard Error - CPT |
11.05; 11.38; 11.8 | >0.05 |
| SECONDARY Detectibility (d') of Continuous Performance Test |
0.71; 1.32; 1.09 | >0.05 |
| SECONDARY Response Style Indicator (Beta) for CPT |
0.95; 1.41; 2.92 | >0.05 |
| SECONDARY Abstinence Related Symptoms - WISDM |
229.14; 229.4; 270.6; 11.57; 15.4; 23.2 | >0.05 |
| SECONDARY Urge to Smoke - MNWS |
36.43; 47; 47; 26.43; 33; 32.4 | >0.05 |
| SECONDARY Abnormal Movements - AIMS |
0.71; 1; 1.40; 0; 0.2; 0.4 | >0.05 |
Summary
There is a strong association between smoking and schizophrenia with prevalence rates ranging from 74% to 90%, versus a national average of 30% in nonschizophrenic individuals. A number of hypotheses have been proposed to explain the relationship between high smoking rates and schizophrenia, mostly relating to self-medication primarily for the negative symptoms of schizophrenia. Smoking cessation rates among schizophrenic patients are considerably lower than for other psychiatric disorders. The negative health effects of smoking increase the morbidity and mortality in schizophrenic patients. Currently, the efficacy of bupropion HCl in the treatment of smoking by schizophrenic subjects is inconclusive, and there have not been any published studies of the efficacy of varenicline in schizophrenic subjects. As varenicline appears to be a promising treatment in non-psychiatric patients, it would be useful to expand these studies to examine its effects in schizophrenic patients. Identifying effective and safe means of smoking cessation for this vulnerable population has the potential to reduce morbidity and mortality among individuals with schizophrenia.
Eligibility Criteria
Inclusion Criteria
- Male or female subjects, 18-75 years old
- Diagnosis of schizophrenia or schizoaffective disorder based on Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria
- Smoking at least 10 cigarettes per day
- Weight of at least 100 lbs (45.4 kg)
- Motivation to quit smoking
- Stabilized psychotic symptoms
- Provision of informed consent for testing and treatment
Exclusion Criteria
- Serious cardiac, renal, hypertensive, pulmonary, endocrine, or neurologic disorder
- Seizure disorder, recent withdrawal from alcohol or anxiolytics
- History of bulimia nervosa, anorexia nervosa, or dementia
- History of depression, panic, or bipolar disorders
- Pregnancy or lactation
- Prior use of varenicline or bupropion HCl within three months prior to initiation of the study
- Current use of other smoking cessation treatments
- Regular use of non-cigarette tobacco products (> than once/week)
- Past substance abuse (alcohol or non-nicotine containing drugs) in the preceding 6 months
- Patients with suicidal ideations or plans
- Florid psychosis or increasing psychosis following varenicline or bupropion HCl treatment
- History of, or current, alcohol dependence/abuse
- Current use of monoamine oxidase inhibitors (MAOI)
Data sourced from ClinicalTrials.gov (NCT01111149). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.