SmokingPhase 1/2NCT00129246
Low-Dose Naltrexone Combined With Bupropion to Stop Smoking With Less Weight Gain
A Phase 1/2 study testing Naltrexone and Bupropion in people with Smoking and Nicotine Dependence, run by Yale University at 1 site in United States.
Trial summary
This study will test a combination of the drugs naltrexone and bupropion with weight-concerned smokers to investigate whether or not this combination of drugs 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
- Smoking, Nicotine Dependence
- What is being tested?
- Naltrexone and Bupropion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Dec 2005
- Phase
- Phase 1/2
- 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
- Ages 18 and older
- Willingness and ability to give written consent
- Smoking at least 10 cigarettes per day for at least 1 year
- Baseline expired carbon-monoxide level of at least 10 ppm
- Weigh at least 100 lbs.
- English-speaking
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- One person per household
- At least 1 prior quit attempt
- Concern about gaining weight. This will be assessed using a questionnaire that will provide a rating system to determine qualified participants.
Who cannot join
- Pregnant or nursing women or women attempting to conceive
- Serious current neurologic, psychiatric or medical illness, including unstable cardiac, hepatic, or renal disease and diabetes and hypertension
- Current alcohol dependence
- Current use of opiates, and/or a urine toxicology screen positive for opiates
- Chronic pain conditions necessitating opioid treatment (naltrexone, an opioid antagonist will make these medications ineffective)
- Evidence of significant hepatocellular injury as evidenced by AST or ALT >3 x normal or elevated bilirubin
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- History of cirrhosis
- Body mass index (BMI) greater than 35
- History of anorexia nervosa or bulimia
- Current major depression
- Currently taking Toprol-XL (or metoprolol succinate)
- History of seizure disorder or serious brain injury
- Current use of smokeless tobacco, pipes, cigars, nicotine gum, nicotine patch, nicotine inhaler, nicotine lozenge, nicotine nasal spray, or bupropion
- Previous hypersensitivity to bupropion
- Patients requiring concomitant therapy with any psychotropic drug
- Participation in the Framing Messages for Smoking Cessation With Bupropion study (HIC#: 10880)
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: Naltrexone & Bupropion to Stop Smoking With Less Weight Gain
This study will test a combination of the drugs naltrexone and bupropion with weight-concerned smokers to investigate whether or not this combination of drugs improves smoking cessation quit rates and minimizes post quit weight gain.
Read the detailed description
This is an open label smoking cessation clinical trial of 25 mg naltrexone with 300 mg bupropion sustained-release (SR) in six male and fourteen female participants. This pilot study is being conducted to determine:
- effect size estimates for smoking cessation and post-cessation weight gain, which will be used to compute the sample size needed for a large-scale clinical trial; and
- compliance with a combination of 25 mg naltrexone and 300 mg bupropion SR. In addition to examining the sample in this study, the investigators plan to compare this sample to a sample of matched controls.
- Conditions
- Smoking, Nicotine Dependence
- Being tested
- Naltrexone, Bupropion
- Keywords
- Tobacco, Smoking, Weight, Weight perception, Naltrexone, Bupropion
- Medical subject headings
- Smoking, Tobacco Use Disorder, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaltrexoneDrug
Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.
BupropionDrug
Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Bupropion only | Active comparator | The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day). Receives: Drug: Bupropion |
| Naltrexone +Bupropion | Experimental | The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only). Receives: Drug: Naltrexone; Drug: Bupropion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Cessation
Smoking cessation is defined as the number of patients that displayed continuous 6-week abstinence from the quit date.
Measured: Week 6
Point Prevalence Abstinence
Point prevalence abstinence is defined as the number of patients reporting point prevalence abstinence over the last 7 days.
Measured: Week 6
Weight Gain
Weight gain for for the entire sample in pounds at 6 weeks.
Measured: Week 6
Secondary outcomes (1)
Weight Gain Abstinent Participants
Weight gain (in pounds) for the patients that were continuously abstinent at 6 weeks.
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2005 (estimated)
- Study startDec 2004
- Study completionDec 2005
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 SmokingStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 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
- Benjamin Toll, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00129246
- Sponsor's protocol ID
- NIAAAOMA15632-B
- Other IDs
- P50AA015632, NIH Grant 9 P50-AA15632
- Status last verified
- Nov 2020
- First submitted
- 9 Aug 2005
- Last updated
- 3 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Toll BA, Leary V, Wu R, Salovey P, Meandzija B, O'Malley SS. A preliminary investigation of naltrexone augmentation of bupropion to stop smoking with less weight gain. Addict Behav. 2008 Jan;33(1):173-9. doi: 10.1016/j.addbeh.2007.05.012. Epub 2007 Jun 2.
PubMed 17587504
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Naltrexone & Bupropion to Stop Smoking With Less Weight Gain
- ClinicalTrials.gov ID
- NCT00129246
- Acronym / sponsor ID
- NIAAAOMA15632-B
- Conditions
- Smoking, Nicotine Dependence
- Keywords
- Tobacco, Smoking, Weight, Weight perception, Naltrexone, Bupropion
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Dec 2004
- Study completion
- Dec 2005 (actual)
- First posted
- 11 Aug 2005 (estimated)
- Results
- Posted 5 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test a combination of the drugs naltrexone and bupropion with weight-concerned smokers to investigate whether or not this combination of drugs improves smoking cessation quit rates and minimizes post quit weight gain.
Detailed description
This is an open label smoking cessation clinical trial of 25 mg naltrexone with 300 mg bupropion sustained-release (SR) in six male and fourteen female participants. This pilot study is being conducted to determine:
- effect size estimates for smoking cessation and post-cessation weight gain, which will be used to compute the sample size needed for a large-scale clinical trial; and
- compliance with a combination of 25 mg naltrexone and 300 mg bupropion SR. In addition to examining the sample in this study, the investigators plan to compare this sample to a sample of matched controls.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupropion only | Active comparator | Drug: BupropionThe placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day). |
| Naltrexone +Bupropion | Experimental | Drug: Naltrexone, Drug: BupropionThe active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Ages 18 and older
- Willingness and ability to give written consent
- Smoking at least 10 cigarettes per day for at least 1 year
- Baseline expired carbon-monoxide level of at least 10 ppm
- Weigh at least 100 lbs.
Key exclusion criteria (16 listed)
- Pregnant or nursing women or women attempting to conceive
- Serious current neurologic, psychiatric or medical illness, including unstable cardiac, hepatic, or renal disease and diabetes and hypertension
- Current alcohol dependence
- Current use of opiates, and/or a urine toxicology screen positive for opiates
- Chronic pain conditions necessitating opioid treatment (naltrexone, an opioid antagonist will make these medications ineffective)
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 |
|---|---|---|
| NaltrexoneParticipants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment. | Drug | Naltrexone +Bupropion |
| BupropionStarting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period. | Drug | Bupropion only, Naltrexone +Bupropion |
Primary outcome
Smoking Cessation
Time frame: Week 6
Smoking cessation is defined as the number of patients that displayed continuous 6-week abstinence from the quit date.
Point Prevalence Abstinence
Time frame: Week 6
Point prevalence abstinence is defined as the number of patients reporting point prevalence abstinence over the last 7 days.
Weight Gain
Time frame: Week 6
Weight gain for for the entire sample in pounds at 6 weeks.
1 secondary outcome
Weight Gain Abstinent Participants
Time frame: Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 17587504Toll BA, Leary V, Wu R, Salovey P, Meandzija B, O'Malley SS. A preliminary investigation of naltrexone augmentation of bupropion to stop smoking with less weight gain. Addict Behav. 2008 Jan;33(1):173-9. doi: 10.1016/j.addbeh.2007.05.012. Epub 2007 Jun 2.
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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.
Benjamin Toll, Ph.D. 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 1/2 study testing Naltrexone and Bupropion in people with Smoking and 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 16 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 3 Dec 2020. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
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 Feb 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?
Smoking Cessation (time frame: Week 6). The study lists 3 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 NCT00129246, 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 3 Dec 2020.