Smoking-Cessation and Stimulant Treatment (S-CAST)

University of Cincinnati538 enrolled

Overview

The primary objective of this study is to evaluate the impact of substance-abuse treatment as usual plus smoking-cessation treatment (TAU+SCT), relative to substance-abuse treatment as usual (TAU), on drug-abuse outcomes. Specifically, this study will evaluate whether concurrent smoking-cessation treatment improves, worsens, or has no effect on stimulant-use outcomes in smokers who are in outpatient substance-abuse treatment for cocaine or methamphetamine dependence.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

538

Conditions

Cocaine Dependence Methamphetamine Dependence Nicotine Dependence

Interventions

Smoking-cessation treatmentOTHER

Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical diagnosis of cocaine/methamphetamine dependence * Smoked cigarettes for at least 3 months * Currently smoking \> 6 cigarettes/day * Have an interest in quitting smoking * Enrolled in outpatient treatment at a participating site Exclusion Criteria: * Clinical diagnosis of current alcohol or sedative dependence, bipolar disorder; or a life-time diagnosis of anorexia nervosa or bulimia * Seeking/receiving treatment for opiate-agonist replacement therapy * Medical conditions that could compromise participant safety * Taking medications with known/potential interactions with bupropion * Hypersensitivity to bupropion, nicotine, or menthol * Pregnant or breastfeeding * Abnormal ECG * Recent smoking cessation treatment * Use of tobacco products other than cigarettes in the past week * Likely to enter residential/inpatient treatment within 10 weeks * Have all stimulant-positive urine drug screens during screening/baseline

Locations (12)

La Frontera

Tucson, Arizona, United States

Matrix Institute on Addictions

Rancho Cucamonga, California, United States

Tarzana Treatment Centers

Tarzana, California, United States

Outcomes

Primary Outcomes

Stimulant-free Weeks Assessed by Self-report and Twice-weekly Urine Drug Screens

Stimulant-free week results (no cocaine, methamphetamine and amphetamine use) were obtained by combining the urine drug screens (UDS) and the self-reported Timeline Follow-Back (TLFB). At the group level, this outcome translates into the percentage of weeks in each study arm that are stimulant-free.

Time frame: Week 16

Secondary Outcomes

Point-prevalence Abstinence (Smoking Outcome)

point-prevalence abstinence defined as not smoking in the previous seven days based on self-report and confirmed with a Carbon Monoxide (CO) level ≤ 8 ppm

Time frame: Week 10 assessment

Four Week Continuous Smoking Abstinence

A combination of daily self-reported smoking data and weekly carbon monoxide levels were used to determine continuous abstinence during post-quit days 15 - 42.

Time frame: Post-quit days 15-42

Stimulant-free Results at 3-month Visit

At the 3-month follow-up visit, percentage of participants with a negative urine drug screen for stimulant use and no stimulant use days reported during the past 28 days based on Timeline Follow-back.

Time frame: 3-month follow-up visit

Point-prevalence Abstinence (Smoking Outcome) 3 Month Visit

point-prevalence abstinence defined as not smoking in the previous seven days based on self-report and confirmed with a Carbon Monoxide (CO) level ≤ 8 ppm

Time frame: 3- month follow-up visits

Stimulant-free Results at 6-month Visit

At the 6-month follow-up visit, percentage of participants with a negative urine drug screen for stimulant use and no stimulant use days reported during the past 28 days based on Timeline Follow-back.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.