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Project 2, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Opioid Abusers (P2S2)

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ClinicalTrials.gov Identifier: NCT02250664
Recruitment Status : Completed
First Posted : September 26, 2014
Last Update Posted : June 11, 2020
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Johns Hopkins University
Information provided by (Responsible Party):
Stephen T. Higgins, PhD, University of Vermont

Tracking Information
First Submitted Date  ICMJE September 23, 2014
First Posted Date  ICMJE September 26, 2014
Last Update Posted Date June 11, 2020
Study Start Date  ICMJE October 2016
Actual Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2014)
Cigarettes per day [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Project 2, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Opioid Abusers
Official Title  ICMJE Project 2, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Opioid Abusers
Brief Summary This study will examine extended exposure to cigarettes varying in nicotine content among opioid abusers. Prevalence of smoking among opioid-dependent adults far exceeds that of the general US adult population. Opioid-dependent smokers are also at elevated risk for smoking-related adverse health effects. Studies testing an innovative regulatory strategy of reducing the nicotine content of cigarettes to a non-addictive level have shown promising beneficial effects (decreased smoking rate, reduced toxicant exposure, and increased cessation) in the general population of smokers. However, these studies have uniformly excluded vulnerable populations like opioid abusers who may respond differently considering their greater vulnerability to smoking and nicotine dependence. Thus, little is known scientifically about how this highly vulnerable subgroup of smokers might respond to a nicotine reduction policy. This project is designed to address that substantial knowledge gap.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Tobacco Use Disorder
Intervention  ICMJE Other: Very low nicotine content cigarettes
Very low nicotine content cigarettes
Study Arms  ICMJE
  • Experimental: 0.8 mg nicotine
    0.8 mg nicotine very low nicotine content cigarettes
    Intervention: Other: Very low nicotine content cigarettes
  • Experimental: 0.12 mg nicotine
    0.12 mg nicotine very low nicotine content cigarettes
    Intervention: Other: Very low nicotine content cigarettes
  • Experimental: 0.03 mg nicotine
    0.03 mg nicotine very low nicotine content cigarettes
    Intervention: Other: Very low nicotine content cigarettes
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: October 5, 2016)
282
Original Estimated Enrollment  ICMJE
 (submitted: September 23, 2014)
405
Actual Study Completion Date  ICMJE October 2019
Actual Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Men and women ages 18-70, who are currently receiving methadone or buprenorphine maintenance treatment for opioid dependence.
  2. Report smoking ≥ 5 cigarettes per day.
  3. Provide an intake breath CO sample >8 ppm.
  4. Be without current (within the past year) serious mental disorder that would interfere with study results or completion as determined by the licensed medical professional or PI.
  5. Be sufficiently literate to complete the research-related tasks.
  6. Be in good physical health without serious illness or change in health or medication (not including methadone or buprenorphine dose) in the past three months as determined by the license medical professional at each site.
  7. Not pregnant or nursing, and report using oral, implant, injection or barrier contraceptives, or report being surgically sterile, or post menopausal.
  8. Report no significant use of other tobacco or nicotine products within the past month (more than 9 days in the past 30).
  9. Participants must be maintained on a stable methadone or buprenorphine dose for the past month, with no evidence of regular illicit-drug abuse (<30% positive specimens in the past 30 days).

    1. Consent to confirm dose and drug abstinence with the participant's opioid clinic will be obtained at screening and we will monitor any changes in dose throughout the study.
    2. Participants must provide at least three urine samples within the last 30 days. If they do not have three they will be asked to come in and provide a sample. They may leave up to two samples per week with at least one full day between samples.

Exclusion Criteria:

  1. Any prior regular use (used as primary cigarette outside of laboratory) of Spectrum cigarettes (i.e., research cigarettes with reduced nicotine content).
  2. Exclusive use of roll-your-own cigarettes.
  3. Planning to quit smoking in the next 30 days.
  4. A quit attempt in the past 30 days resulting in greater than 3 days of abstinence.
  5. Currently taking anticonvulsant medications.
  6. Positive toxicology screen for illicit drugs not including Marijuana ( participants with valid prescriptions will not be excluded and participants with a positive toxicology screen will be allowed to re-screen once).
  7. Not currently enrolled in a treatment program for opioid dependence and/or not currently stable on their methadone or buprenorphine dose.
  8. Breath alcohol level > 0.01 ( participants with a positive screen will be allowed to re-screen once).
  9. Self-report of binge drinking alcohol (more than 9 days in the past 30 days, 4/5 drinks in a 2 hour period in females/males),
  10. Blood pressure is greater than or equal to 160/100 mmHg or below 90/50 mmHg (participants outside the range will be allowed to re-screen once).

    a. Participants failing for blood pressure will be allowed to re-screen once.

  11. Breath CO > 80 ppm.
  12. Heart rate is greater than or equal to 115 bpm or less than 45 bpm ( participants outside the range will be allowed to re-screen once).
  13. Currently seeking treatment for smoking cessation.
  14. Have used nicotine replacement, bupropion or other pharmacotherapies as cessation aids in the past month (bupropion will be allowed for treatment of depression).
  15. Current symptoms of psychosis or dementia, or mania.
  16. Suicidal ideation in the past month. 17.) Suicide attempt in the past 6 months. 18.) Participation in another research study in the past 30 days.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02250664
Other Study ID Numbers  ICMJE P50DA036114:P2S2
P50DA036114 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stephen T. Higgins, PhD, University of Vermont
Study Sponsor  ICMJE University of Vermont
Collaborators  ICMJE
  • National Institute on Drug Abuse (NIDA)
  • Johns Hopkins University
Investigators  ICMJE
Study Director: Stephen T. Higgins, Ph.D. University of Vermont
Principal Investigator: Stacey Sigmon, Ph.D. University of Vermont
PRS Account University of Vermont
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP