Smoking Cessation, Schizophrenia
Conditions
Keywords
smoking cessation, schizophrenia, nicotine nasal spray, behavioral counseling
Brief summary
This R01 grant describes a randomized, double-blind, placebo-controlled trial of nicotine nasal spray (NNS) as an aid for smoking cessation in 60 individuals with schizophrenia. The objectives of this study are to determine the efficacy of NNS with behavioral intervention for smoking cessation in smokers with schizophrenia. It is hypothesized that the quit rate of subjects who receive NNS and behavioral intervention will be significantly greater than the quit rate of the control group who will receive the placebo spray plus same behavioral intervention. Quit rate is defined as the proportion of individuals who self report no tobacco use during weeks 5 through 8 confirmed by exhaled carbon monoxide (CO) less than 10 parts per million during these 4 weeks. The investigators will also assess abstinence rates at Study Weeks 12 and 20 on the NNS and at weeks 26 and 52 after the medication has been stopped. Since studies of this group suggest high relapse rates when treatments are discontinued (Evins et al., 2005; George et al., 2000; George et al., 2002a), the investigators will continue NNS treatment for a total of 20 weeks.
Interventions
minimum 8 doses of nasal spray per day; maximum of 5 doses per hour, no more than 40 doses per day
BEHAVIORALBehavioral counseling
Both groups will receive behavioral intervention designed for schizophrenia delivered as 15 individual counseling sessions over 26 weeks.
Sponsors
National Institute on Drug Abuse (NIDA)
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects will be invited to participate in the study if they fulfill the following inclusion criteria: 1. Meet DSM-IV diagnostic criteria for Schizophrenia 2. Be 18 years of age or older 3. Be daily smokers of 10 or more cigarettes per day (cpd) 4. Have an expired CO level \> 9 ppm 5. Be motivated to quit smoking 6. Be willing to adhere to the study protocol (e.g. provide samples, attend all visits) 7. Be able to give informed consent 8. Stable on their current atypical antipsychotic medication for at least one month.
Exclusion criteria
* Subjects will be excluded based on any one of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Subjects Who Quit Smoking From Weeks 5 to 8 | 4 weeks | Quit rate is defined as the proportion of individuals who self report no tobacco use during weeks 5 through 8 confirmed by exhaled carbon monoxide (CO) less than 10 parts per million (ppm) during these 4 weeks. |
Countries
United States
Participant flow
Recruitment details
141 subjects screened. Of these 66 were consented. Eleven were later found to be ineligible and were dropped prior to randomization. Fifty five subjects were randomized to active or placebo NNS. Three subjects were found to be not eligible after randomization leaving 52 for analysis.
Participants by arm
| Arm | Count |
|---|---|
| NNS Active Receives nicotine (active) nasal spray | 27 |
| Placebo NS Receives placebo (piperine containing) nasal spray | 25 |
| Total | 52 |
Baseline characteristics
| Characteristic | Placebo NS | Total | NNS Active |
|---|---|---|---|
| Age, Continuous | 48.4 years STANDARD_DEVIATION 10.5 | 45.3 years STANDARD_DEVIATION 12 | 42.4 years STANDARD_DEVIATION 12.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 27 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 11 Participants | 22 Participants | 11 Participants |
| Sex: Female, Male Female | 11 Participants | 20 Participants | 9 Participants |
| Sex: Female, Male Male | 14 Participants | 32 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 18 / 27 | 6 / 25 |
| serious Total, serious adverse events | 0 / 27 | 0 / 25 |
Outcome results
Primary
The Number of Subjects Who Quit Smoking From Weeks 5 to 8
Quit rate is defined as the proportion of individuals who self report no tobacco use during weeks 5 through 8 confirmed by exhaled carbon monoxide (CO) less than 10 parts per million (ppm) during these 4 weeks.
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NNS Active | The Number of Subjects Who Quit Smoking From Weeks 5 to 8 | 3 participants |
| Placebo | The Number of Subjects Who Quit Smoking From Weeks 5 to 8 | 1 participants |
Comparison: Fisher Exact test (2-sided)p-value: 0.632Fisher Exact