Tobacco Dependence
Conditions
Keywords
smoking cessation, tobacco dependence treatment, cultural adaptation, Asian Americans
Brief summary
Nicotine dependence is very common among Asian Americans; yet, research on understanding and treating nicotine dependence in this group is almost nonexistent. The proposed study is a first attempt to develop a smoking cessation program that is tailored to Korean-culture specific aspects. It is proposed that Korean Americans who receive a culturally tailored smoking cessation program will be more likely to have prolonged abstinence at 12-month follow-up than their counterparts who receive brief cessation counseling. Subjects in both arms receive nicotine patches for 8 weeks. Self-reported abstinence is validated with exhaled carbon monoxide and salivary cotinine tests.
Detailed description
Korean men have been known for very high smoking rates and the highest cancer death smoking-attributable fraction. In contrast, Korean women reportedly smoke at low rates compared to the general U.S. population. However, recent population-based survey data indicate steady increases in smoking prevalence of Korean American women. Particularly, it has been found that they tend to initiate smoking as they acculturate into social norms of American women. Preliminary data of the applicant and others suggests interventions must be culturally adapted and a motivation-based and family-involved approach is most promising. The training plan will help the applicant develop an independent program of drug abuse research that focuses on better understanding and treating tobacco dependence among Asian Americans, including evaluating culturally competent and gender-specific interventions. The research plan will examine the impact of culture and gender on nicotine dependence and utilize National Institute on Drug Abuse behavioral therapy development methods. The proposed research plan has two-phases and evaluates tobacco dependence treatment with Korean Americans (N = 164, 50% women). Phase 1 is a no-control group study (Stage Ia) that is aimed at developing an intervention manual of Group-based Motivational Interviewing (GMI) intervention, therapists' adherence and competence scales, training program, and small feasibility intervention study with 20 Korean-American (offered separately for men and women). Phase 2 is a randomized controlled trial (Stage Ib) with 144 Korean Americans that is conducted to assess feasibility and relative effectiveness of the GMI behavioral intervention in conjunction with Nicotine Replacement Therapy (NRT) in comparison with a brief group medication management of NRT. Gender-interaction effects of psychosocial variables on treatment outcomes will be assessed, including acculturation and depression. This award will help prepare the applicant for an independent research career focusing on Asian Americans and Nicotine Dependence, including adapting and testing new interventions for different populations.
Interventions
10 minute brief cessation counseling
Deep culturally tailored cognitive behavioral therapy
Sponsors
Study design
Eligibility
Inclusion criteria
Korean-speaking Koreans who: 1. Are ages of 18 and older 2. Have been smoking at least 10 or more cigarettes on average per day for the past 30 days; AND 3. Are willing to quit smoking and receive NRT
Exclusion criteria
1. Inability to speak and understand Korean or English 2. Involvement in behavioral or other pharmacological smoking cessation programs 3. History of serious cardiac diseases and/or presence of skin diseases (see Human Subjects); OR 4. Pregnancy, lactation or plans to become pregnant in the next 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 12-month Abstinence | 12 months | The number of participants who had maintained smoking abstinence for the past 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Family Norm Toward Quitting Smoking | 6-month follow-up | Perceived family norm toward quitting smoking was assessed using the Perceived Family Norm Index consisting of two items assessing normative beliefs (i.e., I believe that my family \[my friends\] wants me to quit smoking) and motivation to comply with the belief (i.e., I am willing to comply with the belief). Score for each item can range from -3 strongly disagree to +3 strongly agree. The total score is the sum of the scores of the two items and can range from -6 to +6. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Biochemical Verification of Self-reported Abstinence | 12-month follow-ups | The salivary cotinine level was assessed by a NicAlert® test, using adopted a cutoff level 2 (30-100ng/ml). |
Countries
United States
Participant flow
Recruitment details
2010-2013.
Pre-assignment details
232 people were screened and 123 were excluded before randomization.
Participants by arm
| Arm | Count |
|---|---|
| Deep Cultural eight weekly 40-minute individualized counseling sessions of cognitive behavioral therapy and cultural tailoring intervention (CBCT) plus 8-week NRT
nicotine patch: 8-week nicotine patch therapy | 55 |
| Standard This arm receives eight, weekly 10-minute brief cessation counseling sessions that are not tailored to Korean culture.
nicotine patch: 8-week nicotine patch therapy | 54 |
| Total | 109 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | Withdrawal by Subject | 11 | 15 |
Baseline characteristics
| Characteristic | Total | Deep Cultural | Standard |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 2 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 105 Participants | 53 Participants | 52 Participants |
| Age, Continuous | 49.73 years STANDARD_DEVIATION 9.28 | 50.69 years STANDARD_DEVIATION 8.41 | 48.76 years STANDARD_DEVIATION 10.08 |
| Region of Enrollment United States | 109 participants | 55 participants | 54 participants |
| Sex: Female, Male Female | 18 Participants | 9 Participants | 9 Participants |
| Sex: Female, Male Male | 91 Participants | 46 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 55 | 0 / 54 |
| serious Total, serious adverse events | 3 / 55 | 2 / 54 |
Outcome results
12-month Abstinence
The number of participants who had maintained smoking abstinence for the past 12 months
Time frame: 12 months
Population: Korean Americans
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cultural Tailoring | 12-month Abstinence | 21 Participants |
| Brief Cessation Counseling | 12-month Abstinence | 6 Participants |
Perceived Family Norm Toward Quitting Smoking
Perceived family norm toward quitting smoking was assessed using the Perceived Family Norm Index consisting of two items assessing normative beliefs (i.e., I believe that my family \[my friends\] wants me to quit smoking) and motivation to comply with the belief (i.e., I am willing to comply with the belief). Score for each item can range from -3 strongly disagree to +3 strongly agree. The total score is the sum of the scores of the two items and can range from -6 to +6.
Time frame: 6-month follow-up
Population: Korean Americans
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cultural Tailoring | Perceived Family Norm Toward Quitting Smoking | 5.14 score on a scale |
| Brief Cessation Counseling | Perceived Family Norm Toward Quitting Smoking | 4.81 score on a scale |
Biochemical Verification of Self-reported Abstinence
The salivary cotinine level was assessed by a NicAlert® test, using adopted a cutoff level 2 (30-100ng/ml).
Time frame: 12-month follow-ups
Population: Korean Americans who had smoked at least 10 cigarettes a day for the past 6 months before study enrollment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cultural Tailoring | Biochemical Verification of Self-reported Abstinence | 21 Participants |
| Brief Cessation Counseling | Biochemical Verification of Self-reported Abstinence | 6 Participants |