SmokingPhase 2NCT00271024
Efficacy of Naltrexone in Women's Smoking Cessation
A Phase 2 study testing Naltrexone (drug) in people with Smoking and Smoking Cessation, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of the proposed study is to conduct a randomized, double-blind clinical trial to compare adjunct treatment with 50 mg oral naltrexone vs. placebo in conjunction with standard smoking cessation treatment with nicotine patch and counseling. Hypotheses: 1. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Smoking Cessation
- What is being tested?
- Naltrexone (drug)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 333 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Mar 2010
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65, male or female
- Cigarette smoker of at least 15 but no more than 40 cigarettes daily for at least two years
- Current diagnosis of DSM-IV Nicotine Dependence, based on SCID interview
- Relatively healthy, with no medical or psychiatric conditions that would adversely interact with study parameters (see exclusion criteria for specific details)
- Desire to quit smoking (self-report rating of interest in quitting at least a 7 on a 10-point scale)
- Nicometer® cotinine level at baseline at least a 5 on a 6-point scale
Show all 9Show fewer
- Reports not quitting smoking in the past three months for more than one week duration
- Agrees to attend behavioral counseling sessions and complete study measures
- Has stable residence and telephone and can provide the name of an outside household collateral family member or close friend
Who cannot join
- Substance Dependence in the last one year (other than DSM-IV Nicotine Dependence) or any history of Opioid Dependence (lifetime)
- Major psychiatric disorder in the last one year, including Axis I disorders or any history of moderate/severe Axis II Disorder, Bipolar Disorder or Psychotic Disorder, based on SCID interview and standard cut-off thresholds on screening questionnaires
- Past or current medical disorders (cardiovascular, hepatic, neurological, endocrine, etc.) which may adversely interact with study measures
- Clinically significant lab test abnormalities, positive urine toxicology, or positive pregnancy test
- Currently pregnant, plans to become pregnant, or lack of effective birth control over next three months, and/or currently lactating, or plans for breastfeeding over next three months
- History of adverse reaction to opioid antagonist or nicotine replacement treatment
Show all 9Show fewer
- Use of any medication that may adversely interact with study measures (antidepressants, phenothiazines, benzodiazepines, etc.); recent or regular use of an opioid medication
- Unwillingness to attend smoking cessation treatment sessions, take the nicotine patch, or be randomized into medication or placebo conditions, or be available for follow-up assessments
- Unwillingness to agree to DNA analysis.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Chicago, Department of Psychiatry
Chicago, Illinois, 60637
About this study
The purpose of the proposed study is to conduct a randomized, double-blind clinical trial to compare adjunct treatment with 50 mg oral naltrexone vs. placebo in conjunction with standard smoking cessation treatment with nicotine patch and counseling.
Hypotheses:
- Naltrexone will improve smoking cessation quit rates, as measured at the end of active treatment (3 months) and during long term follow up (1 year).
- Weight and smoking-related variables (i.e., less weight gain, as well as reduced craving and withdrawal) will be important factors by which naltrexone improves smoking cessation outcome.
- These effects are predicted to be stronger in women compared to men.
Read the detailed description
Although women may be particularly susceptible to the damaging effects of chronic cigarette smoking, evidence indicates that they may have more difficulty in maintaining smoking cessation than men. Given women's reduced response to nicotine replacement and other traditional treatments to habitual cigarette smoking, more targeted pharmacotherapy and intervention strategies may be necessary to improve their quit rates. Preliminary data by our group and others indicate that the opioid antagonist naltrexone may be an effective adjunctive pharmacotherapy approach for female smokers. The purpose of the proposed study is to conduct a randomized clinical trial to compare adjunct treatment with 50 mg oral naltrexone vs. placebo in conjunction with standard smoking cessation treatment with nicotine patch and counseling. Participants (N=324) will be randomized to receive either naltrexone or placebo starting one week prior to the quit date (25 mg for three days; 50 mg thereafter) and continue for 12 weeks after the quit date. The effects of naltrexone will be evaluated during the pre-quit date period, initial smoking cessation, relapse prevention, and at one year follow-up. It is hypothesized that sex will moderate the effects of naltrexone on outcome, with naltrexone improving prolonged abstinence quit rates in women but not in men. The secondary goal will be to elucidate the mechanism underlying women's treatment response to naltrexone. Weight (relative weight gain and weight concerns) and smoking-related variables (reduced cigarette pleasure, taste, craving and relief of negative withdrawal affect) may be important factors by which naltrexone improves quit rates in women. Medication compliance, psychosocial stress and levels of naltrexone's metabolite, 6-B-naltrexol, will also be examined. In sum, the proposed clinical trial will provide a comprehensive study of sex differences in response to adjunct treatment with naltrexone for smoking cessation. Given the public health concerns and significant health consequences of women's continued high rates of smoking, the proposed study may provide important information on a novel treatment strategy targeting the endogenous opioid system to selectively aid in women's smoking cessation.
- Conditions
- Smoking, Smoking Cessation
- Being tested
- Naltrexone (drug), Placebo (for Naltrexone)
- Keywords
- Smoking, Smoking Cessation
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naltrexone (drug)Drug
50 mg q.d. for 13 weeks
Placebo (for Naltrexone)Drug
Sugar pill manufactured to mimic Naltrexone tablet
| Study group | Role | What they receive |
|---|---|---|
| Male Naltrexone | Experimental | 50 mg Naltrexone tablet Receives: Drug: Naltrexone (drug) |
| Female Naltrexone | Experimental | Females receiving either naltrexone (50 mg) Receives: Drug: Naltrexone (drug) |
| Male Placebo | Placebo comparator | Males receiving Placebo (sugar pill) Receives: Drug: Placebo (for Naltrexone) |
| Female Placebo | Placebo comparator | Females receiving placebo (sugar pill) Receives: Drug: Placebo (for Naltrexone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prolonged Smoking Abstinence: 4 Weeks Post Quit-Date
Prolonged Abstinence at 4 weeks post quit date (Study Week 7). Prolonged Abstinence defined as not smoking (even a puff of a cigarette) at any point during the previous time frame, allowing for a 1-week grace period.
Measured: 4 Weeks Following Smoking Quit Date (Study week 7)
Prolonged Smoking Abstinence: 12 Weeks Post Quit-Date
Prolonged Abstinence at 12 weeks post quit date (Study Week 15). Prolonged Abstinence defined as not smoking (even a puff of a cigarette) at any point during the previous time frame, allowing for a 1-week grace period.
Measured: 12 Weeks Following Smoking Quit Date (Study week 15)
7-Day Point Prevalence Smoking Abstinence: 4 Weeks Post Quit-Date
7-Day Point Prevalence smoking abstinence at 4 weeks post quit date (Study Week 7). 7-Day Point Prevalence abstinence defined as not smoking (even a puff) for seven days in a row or on one day in each of two consecutive weeks during the previous time frame.
Measured: 4 Weeks Following Smoking Quit Date (Study week 7)
7-Day Point Prevalence Smoking Abstinence: 12 Weeks Post Quit-Date
7-Day Point Prevalence smoking abstinence at 12 weeks post quit date (Study Week 15). 7-Day Point Prevalence abstinence defined as not smoking (even a puff) for seven days in a row or on one day in each of two consecutive weeks during the previous time frame.
Measured: 12 Weeks Following Smoking Quit Date (Study week 15)
7-Day Point Prevalence Smoking Abstinence: 26 Weeks Post Quit-Date
7-Day Point Prevalence smoking abstinence at 29 weeks post quit date (Study Week 29). 7-Day Point Prevalence abstinence defined as not smoking (even a puff) for seven days in a row or on one day in each of two consecutive weeks during the previous time frame.
Measured: 26 Weeks Following Smoking Quit Date (Study week 29)
7-Day Point Prevalence Smoking Abstinence: 52 Weeks Post Quit-Date
7-Day Point Prevalence smoking abstinence at 52 weeks post quit date (Study Week 55). 7-Day Point Prevalence abstinence defined as not smoking (even a puff) for seven days in a row or on one day in each of two consecutive weeks during the previous time frame.
Measured: 52 Weeks Following Smoking Quit Date (Study week 55)
Secondary outcomes (4)
Weight Change at End of Treatment (Smoking Abstinent Only)
Weight change in lbs at 12 weeks post smoking quit date (study week 15) for only those reporting continued smoking abstinence at the end of treatment. All data are Mean(SEM) and represent positive change, unless otherwise noted. Smoking abstinent for this measure defined as no smoking even 1 puff of a cigarette since the smoking quit date (study week 3), allowing for a 1-week grace period.
Measured: Weight change at 12 weeks post smoking quit date (study week 15)
Weight Change at End of Treatment (Regardless of Quit Status)
Weight change at 12 weeks post quit date (study week 15) for the whole sample regardless of quit status. All data is Mean(SEM) and represents a positive change unless otherwise noted.
Measured: Weight change at 12 weeks post quit date (study week 15) from smoking quit date
Opioid Antagonist Reported Side Effects: 1-Week Post Quit Date
Participants reporting side effects during the previous week by pill type and sex, 1-week following quit date (Study week 4). Participants rated side effects experienced by None, Mild, or Severe.
Measured: 1-Week Post Quit Date (Study Week 4)
Opioid Antagonist Reported Side Effects: 4-Weeks Post Quit Date
Participants reporting side effects during the previous week by pill type and sex, 4-weeks following quit date (Study week 7). Participants rated side effects experienced by None, Mild, or Severe.
Measured: 4-Weeks Post Quit Date (Study Week 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2005 (estimated)
- Study startDec 2005
- Primary completionJun 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 333 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Andrea C King, PhD, Principal investigator, The University of Chicago, Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00271024
- Sponsor's protocol ID
- 13976A (R01 DA016834)
- Other IDs
- R01DA016834
- Status last verified
- Feb 2023
- First submitted
- 28 Dec 2005
- Last updated
- 23 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
King AC, Meyer PJ. Naltrexone alteration of acute smoking response in nicotine-dependent subjects. Pharmacol Biochem Behav. 2000 Jul;66(3):563-72. doi: 10.1016/s0091-3057(00)00258-6.
PubMed 10899371King AC. Role of naltrexone in initial smoking cessation: preliminary findings. Alcohol Clin Exp Res. 2002 Dec;26(12):1942-4. doi: 10.1097/01.ALC.0000041003.44118.9B. No abstract available.
PubMed 12500129Epstein AM, King AC. Naltrexone attenuates acute cigarette smoking behavior. Pharmacol Biochem Behav. 2004 Jan;77(1):29-37. doi: 10.1016/j.pbb.2003.09.017.
PubMed 14724039King A, de Wit H, Riley RC, Cao D, Niaura R, Hatsukami D. Efficacy of naltrexone in smoking cessation: a preliminary study and an examination of sex differences. Nicotine Tob Res. 2006 Oct;8(5):671-82. doi: 10.1080/14622200600789767.
PubMed 17008194King AC, Cao D, Zhang L, O'Malley SS. Naltrexone reduction of long-term smoking cessation weight gain in women but not men: a randomized controlled trial. Biol Psychiatry. 2013 May 1;73(9):924-30. doi: 10.1016/j.biopsych.2012.09.025. Epub 2012 Nov 22.
PubMed 23177384
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Naltrexone in Women's Smoking Cessation
- ClinicalTrials.gov ID
- NCT00271024
- Acronym / sponsor ID
- 13976A (R01 DA016834)
- Conditions
- Smoking, Smoking Cessation
- Keywords
- Smoking, Smoking Cessation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Study start
- Dec 2005
- Primary completion
- Jun 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 29 Dec 2005 (estimated)
- Results
- Posted 26 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the proposed study is to conduct a randomized, double-blind clinical trial to compare adjunct treatment with 50 mg oral naltrexone vs. placebo in conjunction with standard smoking cessation treatment with nicotine patch and counseling.
Hypotheses:
- Naltrexone will improve smoking cessation quit rates, as measured at the end of active treatment (3 months) and during long term follow up (1 year).
- Weight and smoking-related variables (i.e., less weight gain, as well as reduced craving and withdrawal) will be important factors by which naltrexone improves smoking cessation outcome.
- These effects are predicted to be stronger in women compared to men.
Detailed description
Although women may be particularly susceptible to the damaging effects of chronic cigarette smoking, evidence indicates that they may have more difficulty in maintaining smoking cessation than men. Given women's reduced response to nicotine replacement and other traditional treatments to habitual cigarette smoking, more targeted pharmacotherapy and intervention strategies may be necessary to improve their quit rates. Preliminary data by our group and others indicate that the opioid antagonist naltrexone may be an effective adjunctive pharmacotherapy approach for female smokers. The purpose of the proposed study is to conduct a randomized clinical trial to compare adjunct treatment with 50 mg oral naltrexone vs. placebo in conjunction with standard smoking cessation treatment with nicotine patch and counseling. Participants (N=324) will be randomized to receive either naltrexone or placebo starting one week prior to the quit date (25 mg for three days; 50 mg thereafter) and continue for 12 weeks after the quit date. The effects of naltrexone will be evaluated during the pre-quit date period, initial smoking cessation, relapse prevention, and at one year follow-up. It is hypothesized that sex will moderate the effects of naltrexone on outcome, with naltrexone improving prolonged abstinence quit rates in women but not in men. The secondary goal will be to elucidate the mechanism underlying women's treatment response to naltrexone. Weight (relative weight gain and weight concerns) and smoking-related variables (reduced cigarette pleasure, taste, craving and relief of negative withdrawal affect) may be important factors by which naltrexone improves quit rates in women. Medication compliance, psychosocial stress and levels of naltrexone's metabolite, 6-B-naltrexol, will also be examined. In sum, the proposed clinical trial will provide a comprehensive study of sex differences in response to adjunct treatment with naltrexone for smoking cessation. Given the public health concerns and significant health consequences of women's continued high rates of smoking, the proposed study may provide important information on a novel treatment strategy targeting the endogenous opioid system to selectively aid in women's smoking cessation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Male Naltrexone | Experimental | Drug: Naltrexone (drug)50 mg Naltrexone tablet |
| Female Naltrexone | Experimental | Drug: Naltrexone (drug)Females receiving either naltrexone (50 mg) |
| Male Placebo | Placebo comparator | Drug: Placebo (for Naltrexone)Males receiving Placebo (sugar pill) |
| Female Placebo | Placebo comparator | Drug: Placebo (for Naltrexone)Females receiving placebo (sugar pill) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18-65, male or female
- Cigarette smoker of at least 15 but no more than 40 cigarettes daily for at least two years
- Current diagnosis of DSM-IV Nicotine Dependence, based on SCID interview
- Relatively healthy, with no medical or psychiatric conditions that would adversely interact with study parameters (see exclusion criteria for specific details)
- Desire to quit smoking (self-report rating of interest in quitting at least a 7 on a 10-point scale)
Key exclusion criteria (9 listed)
- Substance Dependence in the last one year (other than DSM-IV Nicotine Dependence) or any history of Opioid Dependence (lifetime)
- Major psychiatric disorder in the last one year, including Axis I disorders or any history of moderate/severe Axis II Disorder, Bipolar Disorder or Psychotic Disorder, based on SCID interview and standard cut-off thresholds on screening questionnaires
- Past or current medical disorders (cardiovascular, hepatic, neurological, endocrine, etc.) which may adversely interact with study measures
- Clinically significant lab test abnormalities, positive urine toxicology, or positive pregnancy test
- Currently pregnant, plans to become pregnant, or lack of effective birth control over next three months, and/or currently lactating, or plans for breastfeeding over next three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naltrexone (drug)50 mg q.d. for 13 weeks | Drug | Female Naltrexone, Male Naltrexone |
| Placebo (for Naltrexone)Sugar pill manufactured to mimic Naltrexone tablet | Drug | Female Placebo, Male Placebo |
Primary outcome
Prolonged Smoking Abstinence: 4 Weeks Post Quit-Date
Time frame: 4 Weeks Following Smoking Quit Date (Study week 7)
Prolonged Abstinence at 4 weeks post quit date (Study Week 7). Prolonged Abstinence defined as not smoking (even a puff of a cigarette) at any point during the previous time frame, allowing for a 1-week grace period.
Prolonged Smoking Abstinence: 12 Weeks Post Quit-Date
Time frame: 12 Weeks Following Smoking Quit Date (Study week 15)
Prolonged Abstinence at 12 weeks post quit date (Study Week 15). Prolonged Abstinence defined as not smoking (even a puff of a cigarette) at any point during the previous time frame, allowing for a 1-week grace period.
7-Day Point Prevalence Smoking Abstinence: 4 Weeks Post Quit-Date
Time frame: 4 Weeks Following Smoking Quit Date (Study week 7)
7-Day Point Prevalence smoking abstinence at 4 weeks post quit date (Study Week 7). 7-Day Point Prevalence abstinence defined as not smoking (even a puff) for seven days in a row or on one day in each of two consecutive weeks during the previous time frame.
7-Day Point Prevalence Smoking Abstinence: 12 Weeks Post Quit-Date
Time frame: 12 Weeks Following Smoking Quit Date (Study week 15)
7-Day Point Prevalence smoking abstinence at 12 weeks post quit date (Study Week 15). 7-Day Point Prevalence abstinence defined as not smoking (even a puff) for seven days in a row or on one day in each of two consecutive weeks during the previous time frame.
7-Day Point Prevalence Smoking Abstinence: 26 Weeks Post Quit-Date
Time frame: 26 Weeks Following Smoking Quit Date (Study week 29)
7-Day Point Prevalence smoking abstinence at 29 weeks post quit date (Study Week 29). 7-Day Point Prevalence abstinence defined as not smoking (even a puff) for seven days in a row or on one day in each of two consecutive weeks during the previous time frame.
7-Day Point Prevalence Smoking Abstinence: 52 Weeks Post Quit-Date
Time frame: 52 Weeks Following Smoking Quit Date (Study week 55)
7-Day Point Prevalence smoking abstinence at 52 weeks post quit date (Study Week 55). 7-Day Point Prevalence abstinence defined as not smoking (even a puff) for seven days in a row or on one day in each of two consecutive weeks during the previous time frame.
4 secondary outcomes
Weight Change at End of Treatment (Smoking Abstinent Only)
Time frame: Weight change at 12 weeks post smoking quit date (study week 15)
Weight Change at End of Treatment (Regardless of Quit Status)
Time frame: Weight change at 12 weeks post quit date (study week 15) from smoking quit date
Opioid Antagonist Reported Side Effects: 1-Week Post Quit Date
Time frame: 1-Week Post Quit Date (Study Week 4)
Opioid Antagonist Reported Side Effects: 4-Weeks Post Quit Date
Time frame: 4-Weeks Post Quit Date (Study Week 7)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10899371King AC, Meyer PJ. Naltrexone alteration of acute smoking response in nicotine-dependent subjects. Pharmacol Biochem Behav. 2000 Jul;66(3):563-72. doi: 10.1016/s0091-3057(00)00258-6.
- Background: PubMed 12500129King AC. Role of naltrexone in initial smoking cessation: preliminary findings. Alcohol Clin Exp Res. 2002 Dec;26(12):1942-4. doi: 10.1097/01.ALC.0000041003.44118.9B. No abstract available.
- Background: PubMed 14724039Epstein AM, King AC. Naltrexone attenuates acute cigarette smoking behavior. Pharmacol Biochem Behav. 2004 Jan;77(1):29-37. doi: 10.1016/j.pbb.2003.09.017.
- Background: PubMed 17008194King A, de Wit H, Riley RC, Cao D, Niaura R, Hatsukami D. Efficacy of naltrexone in smoking cessation: a preliminary study and an examination of sex differences. Nicotine Tob Res. 2006 Oct;8(5):671-82. doi: 10.1080/14622200600789767.
- Derived from this study: PubMed 23177384King AC, Cao D, Zhang L, O'Malley SS. Naltrexone reduction of long-term smoking cessation weight gain in women but not men: a randomized controlled trial. Biol Psychiatry. 2013 May 1;73(9):924-30. doi: 10.1016/j.biopsych.2012.09.025. Epub 2012 Nov 22.
- Main Study WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea C King, PhD principal investigator
The University of Chicago, Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Naltrexone (drug) in people with Smoking and Smoking Cessation, run by University of Chicago at 1 site 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 9 inclusion and 9 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 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 26 Apr 2013). 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?
Prolonged Smoking Abstinence: 4 Weeks Post Quit-Date (time frame: 4 Weeks Following Smoking Quit Date (Study week 7)). The study lists 6 primary outcomes in all. 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 NCT00271024, which also lists 5 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 23 Mar 2023.