AlcoholismPhase 4NCT00000447
Behavioral/Drug Therapy for Alcohol-Nicotine Dependence (Naltrexone/Nicotine Patch)
A Phase 4 study testing naltrexone (Revia) and nicotine replacement patch in people with Alcoholism and Smoking, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
This study will develop a behavioral and drug relapse prevention program for individuals who are dependent on both alcohol and tobacco. The study's goal is to show that individuals receiving nicotine replacement therapy and naltrexone (Revia) with behavior therapy will have higher rates of abstinence from both smoking… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Alcoholism, Smoking
- What is being tested?
- naltrexone (Revia) and nicotine replacement patch
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1998to May 2003
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Meets criteria for alcohol and nicotine dependence.
- Individuals will be outpatients with alcohol and nicotine dependence who have completed detoxification (medicated or nonmedicated) within the past 48-120 hours.
- Smoking no less than 10 cigarettes/day and no greater than 50 cigarettes/day.
- Motivated to quit smoking.
- Willing and able to participate in the 12 week outpatient treatment.
- Acceptable health.
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- Able to provide a collateral informant.
- Willing to be followed for 6 months after treatment ends.
- Willing and able to provide the names of three family members or friends to aid in locating participants for follow-up.
Who cannot join
- Current diagnosis of dependence on other substances except nicotine and alcohol.
- Having moderately severe or severe alcohol withdrawal symptoms.
- Recent (less than 48 hours) evidence of hazardous drinking (more than 2 drinks/day for females; 3 drinks/day for males).
- History of opioid abuse.
- Recent use of cocaine.
- Not desiring to quit smoking.
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- Recent past or current pharmacotherapy involving naltrexone or transdermal nicotine systems.
- History of psychosis.
- Current suicidality, homicidally or psychiatric symptoms requiring other medications.
- Presence of medical abnormalities that contraindicate naltrexone or nicotine replacement therapy.
- Current treatment with psychotropic medications.
- Pregnancy or nursing for female patients. Inability or unwillingness to participate in the 12-week outpatient treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center
Houston, Texas, 77030
About this study
Official title: Behavioral/Pharmacological Treatments for Alcohol-Nicotine Dependence
This study will develop a behavioral and drug relapse prevention program for individuals who are dependent on both alcohol and tobacco. The study's goal is to show that individuals receiving nicotine replacement therapy and naltrexone (Revia) with behavior therapy will have higher rates of abstinence from both smoking and drinking than individuals who do not receive the drug therapies. Individuals will be placed in a 12-week outpatient treatment program with followup assessments 1, 3, and 6 months after treatment.
- Conditions
- Alcoholism, Smoking
- Being tested
- naltrexone (Revia), nicotine replacement patch
- Medical subject headings
- Alcoholism, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
naltrexone (Revia)Drug
nicotine replacement patchDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 1999 (estimated)
- Study startSep 1998
- Study completionMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Investigators
- Joy Schmitz, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000447
- Sponsor's protocol ID
- NIAAA-SCHMITZ-11216-04
- Other IDs
- R01AA011216, NIH Grant 5R01AA011216-04
- Status last verified
- Sep 2010
- First submitted
- 2 Nov 1999
- Last updated
- 1 Oct 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral/Pharmacological Treatments for Alcohol-Nicotine Dependence
- ClinicalTrials.gov ID
- NCT00000447
- Acronym / sponsor ID
- NIAAA-SCHMITZ-11216-04
- Conditions
- Alcoholism, Smoking
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Sep 1998
- Study completion
- May 2003 (actual)
- First posted
- 3 Nov 1999 (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.
This study will develop a behavioral and drug relapse prevention program for individuals who are dependent on both alcohol and tobacco. The study's goal is to show that individuals receiving nicotine replacement therapy and naltrexone (Revia) with behavior therapy will have higher rates of abstinence from both smoking and drinking than individuals who do not receive the drug therapies. Individuals will be placed in a 12-week outpatient treatment program with followup assessments 1, 3, and 6 months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Meets criteria for alcohol and nicotine dependence.
- Individuals will be outpatients with alcohol and nicotine dependence who have completed detoxification (medicated or nonmedicated) within the past 48-120 hours.
- Smoking no less than 10 cigarettes/day and no greater than 50 cigarettes/day.
- Motivated to quit smoking.
- Willing and able to participate in the 12 week outpatient treatment.
Key exclusion criteria (12 listed)
- Current diagnosis of dependence on other substances except nicotine and alcohol.
- Having moderately severe or severe alcohol withdrawal symptoms.
- Recent (less than 48 hours) evidence of hazardous drinking (more than 2 drinks/day for females; 3 drinks/day for males).
- History of opioid abuse.
- Recent use of cocaine.
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 (Revia) | Drug | – |
| nicotine replacement patch | 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 1 Oct 2010.
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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.
Joy Schmitz principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing naltrexone (Revia) and nicotine replacement patch in people with Alcoholism and Smoking, run by The University of Texas Health Science Center, Houston 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 1 Oct 2010. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
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 1 Oct 2010.