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Drug AddictionPhase 1NCT01309685

Effect of Varenicline on Tobacco Addiction and on Abstinence-induced Cognitive Impairment

A Phase 1 study testing Varenicline in people with Drug Addiction, run by National Institute on Drug Abuse (NIDA).

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Background: Varenicline (Chantix ) is a drug that is approved by the Food and Drug Administration (FDA) to help people stop smoking. Varenicline is very effective in helping some people quit smoking, but is less effective for others. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Drug Addiction
What is being tested?
Varenicline
How many people
0 participants
Where
No sites listed yet
Study dates
13 Feb 2011to 26 Nov 2014
Phase
Phase 1
Are there results?
None posted in the registry

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 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 18-50 year old males and females
  • smoking at least 10 cigarettes per day for at least 2 years
  • estimated IQ score greater than or equal to 85
  • medically and psychologically healthy as determined by screening criteria

Who cannot join

  • definite plan to reduce or quit tobacco use in the next 30 days
  • treatment for tobacco dependence in the past 3 months
  • use of nicotine replacement products, bupropion, or varenicline in the past 3 months as an aid to quit or reduce smoking
  • use of any oral tobacco product in the past 6 months
  • history of drug or alcohol dependence within last 5 years
  • consumption of more than 15 alcoholic drinks per week on average during the past month
Show all 10Show fewer
  • use of any illicit drug more than once per week on average during the past month
  • current use of any medication that would interfere with the protocol in the opinion of MAI
  • pregnant, nursing, or become pregnant during the study
  • HIV positive

About this study

Official title: Effect of Varenicline on a Laboratory Model of Tobacco Addiction and on Withdrawal-Induced Cognitive Impairment

Background:

  • Varenicline (Chantix ) is a drug that is approved by the Food and Drug Administration (FDA) to help people stop smoking. Varenicline is very effective in helping some people quit smoking, but is less effective for others. Researchers are interested in conducting more in-depth studies into how varenicline works, including its effect on smokers' responses to items that may trigger cigarette cravings, in order to develop better smoking cessation medications.
Read more

Objectives:

  • To examine the effectiveness of varenicline as an effective medication for tobacco addiction by studying its effect on nicotine reinforcement, nicotine-seeking behavior, cue-elicited craving, and performance impairment and craving after overnight tobacco deprivation.

Eligibility:

  • Individuals between 18 and 50 years of age who have been smoking at least 10 cigarettes per day for at least 2 years.

Design:

  • This study will require 12 study visits. Some visits will be brief and other visits that involve test sessions will last up to 8 hours. If no sessions are repeated, the study will take 26 days. Participants will not be required to attempt to quit smoking during this study.
  • Participants will be screened with a full physical examination and medical history, blood and urine tests, and other tests as required by the study researchers.
  • Participants will take two sets of pills during the study: the first set during the first 12 days of the study, followed by a 2-day break, then the second set during the last 12 days. Some of the pills will contain varenicline, and others will be placebos.
  • On Day 1 of the study, participants will come to the National Institute on Drug Abuse to receive the first set of pills. Participants will take the first pill before leaving.
  • On Day 8, participants will have a training session that will measure the amount of carbon monoxide in the breath. Participants will also complete several questionnaires about smoking habits and current mood, and will have a chance to practice the procedures they will do in the study.
  • On Days 9 and 10, participants will have behavioral test sessions that will last 7 to 8 hours. Day 9 will involve tests of cue response to items that may trigger cigarette cravings, and tests of general nicotine cravings over several hours. Day 10 will involve tests of general nicotine cravings over several hours, and then tests of nicotine-seeking behavior. Participants will be provided with lunch during these all-day sessions.
  • On Day 11, participants will have memory and attention tests, and will provide a blood sample. Participants will not be allowed to smoke for 12 hours before the start of the next test on Day 12.
  • On Day 12, participants will provide a breath sample, and will have two sets of memory and attention tests before they will be permitted to start smoking again. There will be no tests on Days 13 and 14.
  • Starting on Day 15, participants will repeat the schedule of tests from Days 1 through 12 with the second set of pills.
Read the detailed description

Objectives

  1. To examine several potential mechanisms by which varenicline functions as an effective medication for tobacco addiction: a) nicotine reinforcement (forced-choice procedure), b) nicotine-seeking behavior (operant response task), c) cue-elicited craving, and d) performance impairment and craving after overnight tobacco deprivation.
  2. To validate our laboratory measures by using a medication with known efficacy in the treatment of tobacco addiction.

Study population

The study will enroll 50 healthy adult smokers to attain 25 completers.

Design

The study is a placebo-controlled, crossover design comparing the effects of varenicline and placebo.

Outcome Measures

During cue-reactivity sessions, primary measures include tobacco craving, mood, and autonomic responsivity (heart rate, blood pressure, skin conductance, and skin temperature). During forced-choice sessions, the primary measure is the percentage of nicotine cigarette puffs chosen during choice trials. During operant response sessions, primary measures include breakpoint (final ratio completed), total number of responses, and number of cigarette puffs earned and taken. During the tobacco deprivation session, primary measures include self-reported withdrawal, tobacco craving, mood, and cognitive task performance (accuracy and response time).

Secondary study measures include baseline demographic and smoking history, level of nicotine dependence, tobacco craving, and mood.

Conditions
Drug Addiction
Being tested
Varenicline
Keywords
Cognition, Smoking, Nicotine, Varenicline, Withdrawal
Medical subject headings
Substance-Related Disorders, Smoking

What participants receive

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

What is being measured

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

  1. Tobacco craving, nicotine reinforcement, cognitive performance

Secondary outcomes (1)

  1. Nicotine dependence, smoking history, mood

Timeline

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

  1. First posted7 Mar 2011 (estimated)
  2. Study start13 Feb 2011
  3. Primary completion26 Nov 2014
  4. Study completion26 Nov 2014

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 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01309685
Sponsor's protocol ID
999911465
Other IDs
11-DA-N465
Status last verified
26 Nov 2012
First submitted
4 Mar 2011
Last updated
6 Oct 2017
Results posted
No

Publications

  • Bell SL, Taylor RC, Singleton EG, Henningfield JE, Heishman SJ. Smoking after nicotine deprivation enhances cognitive performance and decreases tobacco craving in drug abusers. Nicotine Tob Res. 1999 Mar;1(1):45-52. doi: 10.1080/14622299050011141.

    PubMed 11072387

  • Bickel WK, Hughes JR, DeGrandpre RJ, Higgins ST, Rizzuto P. Behavioral economics of drug self-administration. IV. The effects of response requirement on the consumption of and interaction between concurrently available coffee and cigarettes. Psychopharmacology (Berl). 1992;107(2-3):211-6. doi: 10.1007/BF02245139.

    PubMed 1615122

  • Burstein AH, Fullerton T, Clark DJ, Faessel HM. Pharmacokinetics, safety, and tolerability after single and multiple oral doses of varenicline in elderly smokers. J Clin Pharmacol. 2006 Nov;46(11):1234-40. doi: 10.1177/0091270006291837.

    PubMed 17050788

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Varenicline in people with Drug Addiction, run by National Institute on Drug Abuse (NIDA).

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 4 inclusion and 10 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: withdrawn, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Tobacco craving, nicotine reinforcement, cognitive performance. 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 NCT01309685, which also lists 3 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 6 Oct 2017.

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