Tobacco Use DisorderPhase 3NCT00218153
Naltrexone Augmentation of Nicotine Patch Therapy - 1
A Phase 3 study testing Naltrexone in people with Tobacco Use Disorder, run by National Institute on Drug Abuse (NIDA) at 2 sites in United States.
Trial summary
Naltrexone Augmentation of Nicotine Patch Therapy Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Naltrexone
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2000to Apr 2004
- Phase
- Phase 3
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 and older
- Willingness and ability to give written consent
- Smoking 20 cigarettes per day for at least 1 year
- At least one prior attempt to stop smoking
- Baseline expired carbon-monoxide level of at least 10 ppm
- Weigh at least 100 lbs.
- English speaking
- One person per household
Who cannot join
- Pregnant or nursing women or women who do not use a reliable form of birth control
- Unstable cardiac disease
- History of dermatoses
- Current alcohol dependence
- Current use of opiates
- A urine drug screen that is positive for opiates
Show all 11Show fewer
- Serious current neurologic, psychiatric or medical illness
- Chronic pain conditions necessitating opioid treatment
- Evidence of significant hepatocellular injury as evidence by SGOT or SGPT >3 x normal or elevated bilirubin
- Current use of smokeless tobacco, pipes, cigars, nicotine gum or nicotine patch
- Patients requiring concomitant therapy with any psychotropic drug or on any drug with a psychotropic component
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Substance Abuse Treatment Unit
New Haven, Connecticut, 06519
VA Connecticut Health Care System
New Haven, Connecticut, 06519
About this study
Official title: Naltrexone Augmentation of Nicotine Patch Therapy
Naltrexone Augmentation of Nicotine Patch Therapy
Read the detailed description
This double blind placebo controlled study is designed to determine whether naltrexone can be used to help reduce cigarette use and craving for cigarettes. Eligible participants will receive 21mg transdermal nicotine as an outpatient. In addition, participants will receive one of three doses of naltrexone (25,50 or 100mg) or a placebo and brief counseling over the course of six weeks with follow-up appointments three, six, and twelve months after the beginning of treatment.
- Conditions
- Tobacco Use Disorder
- Being tested
- Naltrexone
- Keywords
- nicotine dependence
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaltrexoneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startNov 2000
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Stephanie O'Malley, Ph.D., Principal investigator, Substance Abuse Treatment Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00218153
- Sponsor's protocol ID
- NIDA-13334-1
- Other IDs
- P50-13334-1
- Status last verified
- Sep 2005
- First submitted
- 16 Sep 2005
- Last updated
- 12 Jan 2017
- Results posted
- No
Publications
King 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 23177384O'Malley SS, Krishnan-Sarin S, McKee SA, Leeman RF, Cooney NL, Meandzija B, Wu R, Makuch RW. Dose-dependent reduction of hazardous alcohol use in a placebo-controlled trial of naltrexone for smoking cessation. Int J Neuropsychopharmacol. 2009 Jun;12(5):589-97. doi: 10.1017/S146114570800936X. Epub 2008 Sep 17.
PubMed 18796184
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Naltrexone Augmentation of Nicotine Patch Therapy
- ClinicalTrials.gov ID
- NCT00218153
- Acronym / sponsor ID
- NIDA-13334-1
- Conditions
- Tobacco Use Disorder
- Keywords
- nicotine dependence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Nov 2000
- Study completion
- Apr 2004
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Naltrexone Augmentation of Nicotine Patch Therapy
Detailed description
This double blind placebo controlled study is designed to determine whether naltrexone can be used to help reduce cigarette use and craving for cigarettes. Eligible participants will receive 21mg transdermal nicotine as an outpatient. In addition, participants will receive one of three doses of naltrexone (25,50 or 100mg) or a placebo and brief counseling over the course of six weeks with follow-up appointments three, six, and twelve months after the beginning of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 and older
- Willingness and ability to give written consent
- Smoking 20 cigarettes per day for at least 1 year
- At least one prior attempt to stop smoking
- Baseline expired carbon-monoxide level of at least 10 ppm
Key exclusion criteria (11 listed)
- Pregnant or nursing women or women who do not use a reliable form of birth control
- Unstable cardiac disease
- History of dermatoses
- Current alcohol dependence
- Current use of opiates
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 | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
- 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.
- Derived from this study: PubMed 18796184O'Malley SS, Krishnan-Sarin S, McKee SA, Leeman RF, Cooney NL, Meandzija B, Wu R, Makuch RW. Dose-dependent reduction of hazardous alcohol use in a placebo-controlled trial of naltrexone for smoking cessation. Int J Neuropsychopharmacol. 2009 Jun;12(5):589-97. doi: 10.1017/S146114570800936X. Epub 2008 Sep 17.
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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, Ph.D. principal investigator
Substance Abuse Treatment Unit
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Naltrexone in people with Tobacco Use Disorder, run by National Institute on Drug Abuse (NIDA) at 2 sites 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 8 inclusion and 11 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 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00218153, which also lists 2 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 12 Jan 2017.