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Cocaine DependencePhase 3S-CASTNCT01077024

Smoking-Cessation and Stimulant Treatment (S-CAST)

A Phase 3 study testing Smoking-cessation treatment in people with Cocaine Dependence and Methamphetamine Dependence, run by University of Cincinnati at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Smoking-cessation treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
538 participants
Where
12 sitesUnited States
Study dates
Feb 2010to Aug 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • Gibson Recovery Center, Inc.

    Cape Girardeau, Missouri, 63703

  • Lexington/Richland Alcohol and Drug Abuse Council

    Columbia, South Carolina, 29204

  • Maryhaven

    Columbus, Ohio, 43207

  • Nexus Recovery Center

    Dallas, Texas, 75228

  • Gateway

    Jacksonville, Florida, 32246

  • Behavioral Health Services of Pickens County

    Pickens, South Carolina, 29671

  • Addiction Medicine Services

    Pittsburgh, Pennsylvania, 15213

  • Matrix Institute on Addictions

    Rancho Cucamonga, California, 91730

  • ADAPT

    Roseburg, Oregon, 97470

  • Dorchester

    Summerville, South Carolina, 29483

  • Tarzana Treatment Centers

    Tarzana, California, 91356

  • La Frontera

    Tucson, Arizona, 85713

Other trials in United States

About this study

Official title: Smoking-Cessation and Stimulant Treatment (S-CAST): Evaluation of the Impact of Concurrent Outpatient Smoking-Cessation and Stimulant Treatment on Stimulant-Dependence Outcomes

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.

Being tested
Smoking-cessation treatment
Keywords
Stimulant treatment, Smoking Cessation
Medical subject headings
Cocaine-Related Disorders, Tobacco Use Disorder, Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT01077024
Study groupRoleWhat they receive
Smoking-cessation treatment + substance treatment as usualExperimentalNot described
Receives: Other: Smoking-cessation treatment
Substance-treatment as usualNo interventionTreatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 16

Secondary outcomes (6)

  1. 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

    Measured: Week 10 assessment

  2. 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.

    Measured: Post-quit days 15-42

  3. 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.

    Measured: 3-month follow-up visit

  4. 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

    Measured: 3- month follow-up visits

  5. 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.

    Measured: 6 - months follow-up visit

  6. Point-prevalence Abstinence (Smoking Outcome) 6 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

    Measured: 6 month visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2010 (estimated)
  2. Study startFeb 2010
  3. Primary completionAug 2012
  4. Study completionAug 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
538 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01077024
Sponsor's protocol ID
NIDA-CTN-0046
Other IDs
5U10DA013732, 3U10DA013732-10
Acronym
S-CAST
Status last verified
Sep 2021
First submitted
25 Feb 2010
Last updated
29 Sep 2021
Data monitoring committee
Yes

Publications

  • Winhusen TM, Theobald J, Lewis DF. Substance use outcomes in cocaine-dependent tobacco smokers: A mediation analysis exploring the role of sleep disturbance, craving, anxiety, and depression. J Subst Abuse Treat. 2019 Jan;96:53-57. doi: 10.1016/j.jsat.2018.10.011. Epub 2018 Oct 26.

    PubMed 30466549

  • Winhusen TM, Brigham GS, Kropp F, Lindblad R, Gardin JG 2nd, Penn P, Hodgkins C, Kelly TM, Douaihy A, McCann M, Love LD, DeGravelles E, Bachrach K, Sonne SC, Hiott B, Haynes L, Sharma G, Lewis DF, VanVeldhuisen P, Theobald J, Ghitza U. A randomized trial of concurrent smoking-cessation and substance use disorder treatment in stimulant-dependent smokers. J Clin Psychiatry. 2014 Apr;75(4):336-43. doi: 10.4088/JCP.13m08449.

    PubMed 24345356

  • Winhusen TM, Kropp F, Theobald J, Lewis DF. Achieving smoking abstinence is associated with decreased cocaine use in cocaine-dependent patients receiving smoking-cessation treatment. Drug Alcohol Depend. 2014 Jan 1;134:391-395. doi: 10.1016/j.drugalcdep.2013.09.019. Epub 2013 Sep 27.

    PubMed 24128381

  • Winhusen TM, Adinoff B, Lewis DF, Brigham GS, Gardin JG 2nd, Sonne SC, Theobald J, Ghitza U. A tale of two stimulants: mentholated cigarettes may play a role in cocaine, but not methamphetamine, dependence. Drug Alcohol Depend. 2013 Dec 15;133(3):845-51. doi: 10.1016/j.drugalcdep.2013.09.002. Epub 2013 Sep 11.

    PubMed 24075226

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Smoking-cessation treatment in people with Cocaine Dependence and Methamphetamine Dependence, run by University of Cincinnati at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stimulant-free Weeks Assessed by Self-report and Twice-weekly Urine Drug Screens (time frame: Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01077024, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.

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