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Very Low-Nicotine Cigarettes in Smokers With SUD (VLNC)

This study is currently recruiting participants.
Verified August 2017 by Damaris J. Rohsenow, Ph.D., Brown University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01989507
First Posted: November 21, 2013
Last Update Posted: August 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Damaris J. Rohsenow, Ph.D., Brown University
  Purpose
The purpose of this study is to determine the efficacy, acceptability and unintended consequences of very low nicotine content cigarettes (VLNCC) in smokers with current or past year substance use disorders (SUD). The primary aim of this study is to determine whether 6 weeks of VLNCC compared to normal nicotine content cigarettes (NNCC) will result in more smoking cessation over 6 months and reduce cigarette use, cotinine, and biomarkers of toxicity. We will also assess the effects of VLNCC versus NNCC cigarettes on frequency of substance use and substance cravings (drugs and alcohol) because this is relevant to the safety of these products among smokers with SUD. Secondary aims are to study effects on cigarette craving, nicotine withdrawal and dependence, and depressed mood. Methods: Random assignment to VLNCC versus NNCC of up to 312 smokers with SUD will be balanced by gender, degree of tobacco dependence, and recent drug and alcohol use. All smokers will be provided with smoking counseling. Assessments over 6 months will assess effects both during the 6 weeks of using research cigarettes and after return to usual cigarettes. The importance is in determining the viability and safety of this public health strategy in terms of effects on both smoking and other substance use in a highly addicted population, which is essential to determine before the FDA implements this policy.

Condition Intervention Phase
Nicotine Dependence Drug: Nicotine Behavioral: behavioral counseling for smoking cessation Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Very Low-Nicotine Cigarettes in Smokers With SUD: Smoking, Substance Use Effects

Resource links provided by NLM:


Further study details as provided by Damaris J. Rohsenow, Ph.D., Brown University:

Primary Outcome Measures:
  • 7-day point-prevalence smoking abstinence [ Time Frame: 6 weeks ]
    self-report of past 7 days abstinence confirmed by expired carbon monoxide (CO) reading of 6 ppm or less


Secondary Outcome Measures:
  • Total N'-nitrosonornicotine (NNAL) [ Time Frame: 6 weeks ]
    Urinary N'-nitrosonornicotine and its glucuronide provide a measure of metabolites of the tobacco-specific carcinogen N'-nitrosonornicotine

  • Number of cigarettes smoked per day [ Time Frame: 6 weeks ]
    Time Line Follow Back for tobacco use will assess self-reported number of cigarettes smoked each day

  • Number of substance use days [ Time Frame: 6 months ]
    Time Line Follow Back will assess self-reported number of days of drinking or drug use. Any days of either will be counted as a substance use day.

  • Change in Beck Depression Inventory [ Time Frame: Baseline and 6 weeks ]
    Beck Depression Inventory will be administered at baseline and 6 weeks to detect any change in depression scores from baseline

  • Total N'-nitrosonornicotine (NNN) [ Time Frame: 6 weeks ]
    Urinary N'-nitrosonornicotine and its glucuronide provide a measure of metabolites of the tobacco-specific carcinogen N'-nitrosonornicotine

  • 3-hydroxypyrene (3-HOP) [ Time Frame: 6 weeks ]
    Urinary 3-hydroxypyrene and its glucuronide and sulfate provides a measure of a metabolite of pyrene, a biomarker for uptake of carcinogenic polycyclic aromatic hydrocarbons

  • 3-hydroxypropylmercapturic acid (3-HPMA) [ Time Frame: 6 weeks ]
    Urinary 3-hydroxypropylmercapturic acid (3-HPMA) provides a measure of a metabolite of the toxicant acrolein

  • Total urinary cotinine levels [ Time Frame: 6 weeks ]
    cotinine plus cotinine-glucuronide, assessed via urinalysis

  • duration of longest tobacco abstinence period [ Time Frame: 6 weeks ]
    Time Line Follow Back (TLFB) for tobacco use will be used to record self-reported tobacco abstinence each day. The longest number of contiguous abstinence days will be recorded.

  • Questionnaire of Smoking Urges, Brief Form [ Time Frame: 6 weeks ]
    Questionnaire of Smoking Urges, Brief Form assesses strong desire/intention to smoke and anticipating negative-affect relief from smoking. The total score from the 10 items will be used.


Other Outcome Measures:
  • Minnesota Nicotine Withdrawal Scale [ Time Frame: 6 weeks ]
    ratings of 7 nicotine withdrawal symptoms will be combined to form a single score for withdrawal

  • Penn Alcohol Craving Scale [ Time Frame: 6 weeks ]
    Assessment of craving for alcohol over the previous week. Administered weekly for 6 weeks, the mean of the 6 weeks will be used as the outcome variable.

  • Drug Craving Questionnaire [ Time Frame: 6 weeks ]
    Adapted from Tiffany's Cocaine Craving Questionnaire to assess craving for any drugs over the previous week. Administered weekly for 6 weeks, the mean of the scores over 6 weeks will be used as the outcome variable.

  • Change in Contemplation Ladder [ Time Frame: Baseline and 6 weeks ]
    The 10-point Contemplation Ladder provides a single continuous measure of motivation to quit smoking. Change from baseline to 6 weeks will be used as the outcome.


Estimated Enrollment: 250
Actual Study Start Date: April 2014
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Very low nicotine content cigarettes
Cigarettes with Nicotine Yield 0.07 ± 0.02
Drug: Nicotine Behavioral: behavioral counseling for smoking cessation
Brief session of Brief advice. Assess smoking and provide assistance with quitting via coping skills.
Active Comparator: Conventional nicotine content cigarettes
Cigarettes with Nicotine Yield 0.8 ± 0.15
Drug: Nicotine Behavioral: behavioral counseling for smoking cessation
Brief session of Brief advice. Assess smoking and provide assistance with quitting via coping skills.

Detailed Description:
The 2009 passage of the Family Smoking Prevention and Tobacco Control Act (FSPTCA) gave the Food and Drug Administration (FDA) the authority to reduce levels of nicotine in cigarettes if appropriate for public health. This project addresses an area targeted for study by NIH and the FDA to assess the impact of products with reduced toxicity on tobacco use behaviors. Very-low nicotine content cigarettes (VLNCC) have been shown in some studies with smokers from the general population to reduce craving and withdrawal for tobacco relative to abstinence with little or no compensatory smoking, suggesting that a mandated reduction in the nicotine yield of cigarettes could substantially reduce smoking rates. This may be a particularly effective method of reducing smoking and smoking-related disease in special populations that have very high rates of tobacco dependence, such as people with substance use disorders (SUD). However, the consequences of this policy for smokers with SUD have not been investigated, and a call has gone out for studies of the safety of these products with vulnerable populations such as these. The purpose of this study is to determine the efficacy, acceptability and unintended consequences of VLNCC in smokers with SUD (current or past year) currently abstinent from hard drugs. The primary aims are to determine whether VLNCC will increase smoking cessation and reduce cigarette use, cotinine, and biomarkers of toxicity in smokers with SUD relative to baseline and to those randomized to a normal nicotine content cigarette (NNCC), and to determine any unintended effects of VLNCC on substance use and cravings to use substances so as to investigate safety. Secondary aims are to study effects on cigarette craving and nicotine withdrawal and dependence (mechanisms), and state depression (safety). A 2-group between-group by pre-post design will compare 6 weeks of VLNCC to NNCC; all smokers will also be provided with smoking counseling. Follow-up over 6 months will assess effects after return to usual cigarettes. The importance is in determining the viability and safety of this public health strategy in terms of effects on both smoking and other substance use in a highly addicted population, which is essential to determine before the FDA implements this policy.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria::

  • Diagnostic and Statistical Manual-5 criteria for current or past year substance use disorder
  • smoke 10+ cigarettes/day for past 6 months
  • zero breath alcohol, negative urine drug tests and a self-report of no drug use in the past 30 days on day of informed consent
  • score of 4-8 on the Contemplation Ladder (individuals interested in quitting smoking someday and/or have thought about quitting)

Exclusion Criteria:

  • active psychosis as evidenced by hallucinations or delusions
  • actively quitting smoking or current use of any nicotine replacement or other smoking cessation treatment
  • medication contraindications for smoking cessation (smoking cessation may change the bioavailability of antipsychotics, warfarin, theophylline and insulin)
  • other medications that could affect smoking (naltrexone, buprenorphine, acamprosate, anti-seizure medications, disulfiram)
  • if on psychotropic medications, not stabilized on psychotropic medications (i.e., anti-depressant, anti-anxiety or anti-manic medications changed within past 4 weeks)
  • inability to understand informed consent in a test (true-false questions) on the key elements of the consent form
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01989507


Contacts
Contact: Rosemarie A Martin, PhD 4018636656 Rosemarie_Martin@brown.edu
Contact: Jennifer Duff 401-863-6667 Jennifer_duff@brown.edu

Locations
United States, Rhode Island
Brown University's Center for Alcohol and Addiction Studies Recruiting
Providence, Rhode Island, United States, 02912
Contact: Damaris J Rohsenow, PhD    401-863-6648    Damaris_Rohsenow@Brown.edu   
Principal Investigator: Damaris J Rohsenow, PhD         
Sponsors and Collaborators
Brown University
Investigators
Principal Investigator: Damaris J Rohsenow, PhD Brown University
Study Director: Rosemarie A Martin, PhD Brown University
  More Information

Responsible Party: Damaris J. Rohsenow, Ph.D., Principal Investigator, Brown University
ClinicalTrials.gov Identifier: NCT01989507     History of Changes
Other Study ID Numbers: R01DA034628-01A1 ( U.S. NIH Grant/Contract )
First Submitted: November 12, 2013
First Posted: November 21, 2013
Last Update Posted: August 28, 2017
Last Verified: August 2017

Keywords provided by Damaris J. Rohsenow, Ph.D., Brown University:
tobacco smoking
smoking cessation
nicotine dependence
tobacco use disorder

Additional relevant MeSH terms:
Nicotine
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action