Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to investigate the feasibility of a mobile-phone based contingency management (CM) intervention for smoking in low-SES women. The CM intervention will be combined with a Brief Motivational Interviewing (BMI) counseling component. This study will examine the following research aims:

Primary Aim: To compare the effects of a Brief Motivational Intervention (BMI) + mobile phone-based CM on tobacco use when compared to BMI with a non-contingent control condition in a small feasibility trial.

Hypothesis: The investigators expect women in the BMI + CM condition to have more smoke free days than women in the BMI + NC condition.

Secondary Aim: To examine alcohol use as a moderator of cessation outcomes.


Clinical Trial Description

Cigarette smoking is the leading cause of preventable death in the United States, accounting for one out of every five deaths (CDC, 2012). In particular, smoking prevalence rates are high among socioeconomically-disadvantaged women; for example, over 40% of women with less than 12 yrs education smoke, compared to 28% and 16% among those with some college and undergraduate degrees (SAMHSA, 2010). Smoking cessation rates are particularly low among low-SES women with co-occurring alcohol use disorders, and these substances are frequently used together (Kahler et al., 2010; Businelle et al., 2013). Therefore, interventions that reduce both alcohol and smoking among heavy alcohol-using women are vitally needed to reduce rates of smoking-related morbidity and mortality in this vulnerable population.

Counseling approaches that incorporate problem solving, skills training and social support are effective for reducing smoking in the general population (Fiore et al., 2008). However, given the high rates of smoking among alcohol-using women, they may be inadequate for in this population. Contingency management (CM) interventions, which provide tangible reinforcers contingent upon smoking abstinence or reduction to a criterion level, are highly-efficacious interventions for reducing cigarette smoking and other drug use in low-SES women (Higgins et al., 2012). Within the theoretical framework of operant conditioning, increasing the availability of an alternative reinforcer weakens the amount of control that the drug has over the user's behavior, especially when obtaining the alternative reinforcer is contingent on behaviors incompatible with drug use (Higgins, 1997). The tenets of CM interventions include (1) arranging the environment such that the target behavior can be readily and objectively detected, (2) providing a tangible reinforcer when the target behavior occurs, and (3) withholding reinforcement when the target behavior does not occur (Higgins et al., 1994).

Although CM interventions clearly are effective at promoting smoking reductions, there are several challenges associated with translating CM into an effective clinical treatment for smoking. Perhaps the most significant challenge is the frequent monitoring necessary to objectively verify smoking abstinence using breath carbon monoxide (CO), the most convenient objective measure of smoking status. Because of the short half-life of CO (5-6 hours), CO levels must be measured at least twice per day in order to verify continuous abstinence. Recent CM-smoking studies have addressed this feasibility challenge by providing study participants with breath CO monitors and laptop computers or smartphones to use in their own natural environments (e.g., Dallery, Raiff & Grabinski, 2013). Participants are taught how to use their smartphones to text videos of themselves providing a breath CO level to a research staff member, twice per day. After the study staff has determined that the breath CO sample meets the abstinence criterion, participants are informed of the amount that they have earned for that sample.

Given the high rates of smoking in low-SES women, investigating the additive impact of an in-person brief counseling intervention and a phone-based CM intervention is an important next step in examining effective methods to reduce the impact of smoking in this population. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03173274
Study type Interventional
Source Brown University
Contact
Status Terminated
Phase N/A
Start date February 8, 2018
Completion date March 3, 2018

See also
  Status Clinical Trial Phase
Recruiting NCT05176418 - IV Pulsed-Nicotine as a Model of Smoking: The Effects of Dose and Delivery Rate Early Phase 1
Completed NCT04084210 - Impact of Alternative Nicotine-Delivery Products on Combustible Cigarette Use Phase 2
Completed NCT04043728 - Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study N/A
Withdrawn NCT03707600 - State and Trait Mediated Response to TMS in Substance Use Disorder N/A
Recruiting NCT03999099 - Targeting Orexin to Treat Nicotine Dependence Phase 1
Completed NCT03847155 - Prevention of Nicotine Abstinence in Critically Ill Patients After Major Surgery N/A
Completed NCT02840435 - Study on Sit to Quit Phone Intervention N/A
Completed NCT02139930 - Project 2: Strategies for Reducing Nicotine Content in Cigarettes N/A
Completed NCT01982110 - A Mindfulness Based Application for Smoking Cessation N/A
Completed NCT01926626 - Evaluation of Moclobemide, a Reversible MAO-A Inhibitor, as an Adjunct to Nicotine Replacement Therapy in Female Smokers Phase 2
Completed NCT01569490 - Striving to Quit: First Breath N/A
Withdrawn NCT01569477 - Striving to Quit-Wisconsin Tobacco Quit Line N/A
Completed NCT01685996 - Zonisamide Augmentation of Varenicline Treatment for Smoking Cessation Phase 1/Phase 2
Completed NCT01632189 - The Effect of Varenicline on D2/D3 Receptor Binding in Smokers N/A
Active, not recruiting NCT01182766 - New Treatment for Alcohol and Nicotine Dependence Phase 2/Phase 3
Completed NCT00996034 - Nicotine Vaccination and Nicotinic Receptor Occupancy Phase 2
Completed NCT01061528 - Coping Skills Treatment for Smoking Cessation N/A
Suspended NCT01636336 - Effects of Progesterone on Smoked Nicotine Induced Changes in Hormones and Subjective Ratings of Stimulant Drug Effects N/A
Completed NCT01943994 - Psilocybin-facilitated Smoking Cessation Treatment: A Pilot Study N/A
Withdrawn NCT01589081 - Effects of Progesterone on IV Nicotine-Induced Changes in Hormones and Subjective Ratings of Stimulant Drug Effect N/A