Nicotine DependencePhase 2NCT00105482
Targeted Interventions for Weight-Concerned Smokers
A Phase 2 study testing Naltrexone, Transdermal nicotine replacement and Behavioral counseling in people with Nicotine Dependence, run by Yale University at 1 site in United States.
Trial summary
Weight gain after quitting smoking is an important barrier to treatment for many smokers. This study will test a drug called naltrexone with weight-concerned smokers to investigate whether or not this drug both improves smoking cessation quit rates and minimizes post quit weight gain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Naltrexone, Transdermal nicotine replacement and Behavioral counseling
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 172 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Oct 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Concern about gaining weight after quitting. This will be assessed using questionnaires that will provide a rating system to determine qualified participants.
- 2. Age 18 and older.
- 3. Willingness and ability to give written consent.
- 4. Smoking greater than 10 cigarettes per day for at least 1 year.
- 5. At least one prior attempt to stop smoking.
- 6. Baseline expired carbon-monoxide level of at least 10 ppm.
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- 7. Weigh at least 100 lbs.
- 8. English speaking.
- 9. One person per household.
Who cannot join
- 1. Pregnant or nursing women or women attempting to conceive.
- 2. Unstable cardiac disease.
- 3. History of dermatoses.
- 4. Current alcohol or drug dependence other than nicotine dependence.
- 5. Serious current neurologic, psychiatric or medical illness, including those with a significant risk of committing suicide based on history or investigator's judgment.
- 6. Chronic pain conditions necessitating opioid treatment (naltrexone, an opioid antagonist, will make these medications ineffective).
Show all 12Show fewer
- 7. History of cirrhosis or significant hepatocellular injury as evidenced by SGOT or SGPT >3 x normal or elevated bilirubin.
- 8. Current use of smokeless tobacco, pipes, cigars, nicotine gum, patch, nasal spray, inhaler, or lozenges.
- 9. Patients requiring concomitant therapy with any psychotropic drug or on any drug with a psychotropic component except those who are on a stable dose of an Selective Serotonin Reuptake Inhibitor for at least two months for the indications of Major Depressive Disorder, Premenstrual Syndrome (PMS) or Premenstrual Dysphoric Disorder (PMDD).
- 10. Subjects with a positive opiate urine drug screen will be excluded to avoid precipitating opiate withdrawal.
- 11. Current use of opiates.
- 12. Currently on a medically prescribed diet.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine Substance Abuse Treatment Unit
New Haven, Connecticut, 06511
About this study
Official title: Testing the Effectiveness of Low Dose Naltrexone for Smoking Cessation and Minimization of Post-cessation Weight Gain
Weight gain after quitting smoking is an important barrier to treatment for many smokers. This study will test a drug called naltrexone with weight-concerned smokers to investigate whether or not this drug both improves smoking cessation quit rates and minimizes post quit weight gain.
Read the detailed description
This is a 6-month randomized, double-blind, placebo controlled trial of 25 mg naltrexone for smoking cessation in a sample of 270 male and female weight-concerned smokers. Participants also receive transdermal nicotine replacement therapy during the first 8 weeks of the study, which they begin on their quit date. Naltrexone study medication will be started a week before their quit date and continued through the six-month period. Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter. A follow-up appointment is completed at 12 months after participants' quit date.
The primary outcomes are six-month point prevalence abstinence and post-cessation weight gain for those who are continuously abstinent (not even a puff).
Secondary outcomes include an examination of alcohol consumption, evaluation of urges, other measures of smoking cessation success, point prevalence abstinence at 12 months, and food preferences. A number of tertiary measures will be obtained for examining predictors of smoking cessation, weight gain, and naltrexone response.
- Conditions
- Nicotine Dependence
- Being tested
- Naltrexone, Transdermal nicotine replacement, Behavioral counseling
- Keywords
- Tobacco, Smoking, Weight, Weight perception, Naltrexone
- Medical subject headings
- Tobacco Use Disorder, Smoking, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaltrexoneDrug
Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks
Transdermal nicotine replacementDrug
Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day
Behavioral counselingBehavioural
Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter.
| Study group | Role | What they receive |
|---|---|---|
| Naltrexone, Transdermal Nicotine | Experimental | Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day Receives: Drug: Naltrexone; Drug: Transdermal nicotine replacement; Behavioral: Behavioral counseling |
| Placebo Naltrexone, Transdermal Nicotine | Placebo comparator | Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day Receives: Drug: Transdermal nicotine replacement; Behavioral: Behavioral counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Gain at 26 Weeks.
Weight change from baseline measured at 26 weeks.
Measured: 26 weeks
Point Prevalence Smoking Abstinence at 26 Weeks.
The number of people that were abstinent from cigarette smoking at 26 weeks.
Measured: 26 weeks
Secondary outcomes (3)
Weight Gain at 6 Weeks.
Weight change from baseline measured at 6 weeks.
Measured: 6 weeks
Point Prevalence Smoking Abstinence at 6 Weeks
The number of people that were abstinent from cigarette smoking at 6 weeks.
Measured: 6 weeks
Cigarettes Smoked Per Day.
Average number of cigarettes smoked per day at 26 weeks.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2005 (estimated)
- Study startJan 2005
- Primary completionApr 2009
- Study completionOct 2009
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 (1)Papers the sponsor has linked to this study.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Stephanie O'Malley, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00105482
- Sponsor's protocol ID
- NIAAAOMA15632
- Other IDs
- P50AA015632, 9P50AA015632
- Status last verified
- Jan 2013
- First submitted
- 14 Mar 2005
- Last updated
- 5 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Toll BA, White M, Wu R, Meandzija B, Jatlow P, Makuch R, O'Malley SS. Low-dose naltrexone augmentation of nicotine replacement for smoking cessation with reduced weight gain: a randomized trial. Drug Alcohol Depend. 2010 Oct 1;111(3):200-6. doi: 10.1016/j.drugalcdep.2010.04.015. Epub 2010 Jun 12.
PubMed 20542391
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Effectiveness of Low Dose Naltrexone for Smoking Cessation and Minimization of Post-cessation Weight Gain
- ClinicalTrials.gov ID
- NCT00105482
- Acronym / sponsor ID
- NIAAAOMA15632
- Conditions
- Nicotine Dependence
- Keywords
- Tobacco, Smoking, Weight, Weight perception, Naltrexone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Jan 2005
- Primary completion
- Apr 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 15 Mar 2005 (estimated)
- Results
- Posted 5 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Weight gain after quitting smoking is an important barrier to treatment for many smokers. This study will test a drug called naltrexone with weight-concerned smokers to investigate whether or not this drug both improves smoking cessation quit rates and minimizes post quit weight gain.
Detailed description
This is a 6-month randomized, double-blind, placebo controlled trial of 25 mg naltrexone for smoking cessation in a sample of 270 male and female weight-concerned smokers. Participants also receive transdermal nicotine replacement therapy during the first 8 weeks of the study, which they begin on their quit date. Naltrexone study medication will be started a week before their quit date and continued through the six-month period. Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter. A follow-up appointment is completed at 12 months after participants' quit date.
The primary outcomes are six-month point prevalence abstinence and post-cessation weight gain for those who are continuously abstinent (not even a puff).
Secondary outcomes include an examination of alcohol consumption, evaluation of urges, other measures of smoking cessation success, point prevalence abstinence at 12 months, and food preferences. A number of tertiary measures will be obtained for examining predictors of smoking cessation, weight gain, and naltrexone response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naltrexone, Transdermal Nicotine | Experimental | Drug: Naltrexone, Drug: Transdermal nicotine replacement, Behavioral: Behavioral counselingArm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day |
| Placebo Naltrexone, Transdermal Nicotine | Placebo comparator | Drug: Transdermal nicotine replacement, Behavioral: Behavioral counselingArm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1. Concern about gaining weight after quitting. This will be assessed using questionnaires that will provide a rating system to determine qualified participants.
- 2. Age 18 and older.
- 3. Willingness and ability to give written consent.
- 4. Smoking greater than 10 cigarettes per day for at least 1 year.
- 5. At least one prior attempt to stop smoking.
Key exclusion criteria (12 listed)
- 1. Pregnant or nursing women or women attempting to conceive.
- 2. Unstable cardiac disease.
- 3. History of dermatoses.
- 4. Current alcohol or drug dependence other than nicotine dependence.
- 5. Serious current neurologic, psychiatric or medical illness, including those with a significant risk of committing suicide based on history or investigator's judgment.
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 |
|---|---|---|
| NaltrexoneDrug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks | Drug | Naltrexone, Transdermal Nicotine |
| Transdermal nicotine replacementTransdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day | Drug | Naltrexone, Transdermal Nicotine, Placebo Naltrexone, Transdermal Nicotine |
| Behavioral counselingBrief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter. | Behavioural | Naltrexone, Transdermal Nicotine, Placebo Naltrexone, Transdermal Nicotine |
Primary outcome
Weight Gain at 26 Weeks.
Time frame: 26 weeks
Weight change from baseline measured at 26 weeks.
Point Prevalence Smoking Abstinence at 26 Weeks.
Time frame: 26 weeks
The number of people that were abstinent from cigarette smoking at 26 weeks.
3 secondary outcomes
Weight Gain at 6 Weeks.
Time frame: 6 weeks
Point Prevalence Smoking Abstinence at 6 Weeks
Time frame: 6 weeks
Cigarettes Smoked Per Day.
Time frame: 26 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20542391Toll BA, White M, Wu R, Meandzija B, Jatlow P, Makuch R, O'Malley SS. Low-dose naltrexone augmentation of nicotine replacement for smoking cessation with reduced weight gain: a randomized trial. Drug Alcohol Depend. 2010 Oct 1;111(3):200-6. doi: 10.1016/j.drugalcdep.2010.04.015. Epub 2010 Jun 12.
- This website describes the Transdisciplinary Tobacco Use Research Center at Yale University. Click here for more information about the study: Targeted Interventions for Weight-concerned Smokers.Link 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.
Stephanie O'Malley, PhD principal investigator
Yale University
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, Transdermal nicotine replacement and Behavioral counseling in people with Nicotine Dependence, run by Yale University 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 12 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 5 Mar 2013. 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 5 Mar 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?
Weight Gain at 26 Weeks. (time frame: 26 weeks). The study lists 2 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 NCT00105482, which also lists 1 linked publication.
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 5 Mar 2013.