Tobacco Use DisorderPhase 2/3NCT00064922
Incentive Programs for Female Substance Abusers Who Smoke - 3
A Phase 2/3 study testing Behavior Therapy in people with Tobacco Use Disorder, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
The purpose of this study is to examine the effects of incentive programs for the treatment of nicotine dependence in women who have problems with substance dependence. Read more about this study
- Who is it for?
- Ages 15 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Behavior Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to Apr 2006
- Phase
- Phase 2/3
- 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 15 to 99 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnant and or post-partum with at least one child under 1 year old living with them, or non-pregnant, non-post-partum females or previous participant in this study protocol
- Nicotine Dependent as confirmed by DSM-IV checklist
- Current cigarette smoker
- Breath CO reading of at least 8 ppm at the time of the initial study screening
- Current client with the Shields for Families (Shields) treatment programs
Who cannot join
- Non-smoker
Trial locations and contacts
1 site in 1 country.
United States1 site
Shields for Families, Inc.
Los Angeles, California, 90061
About this study
Official title: Incentive Programs for Female Substance Abusers Who Smoke
The purpose of this study is to examine the effects of incentive programs for the treatment of nicotine dependence in women who have problems with substance dependence.
Read the detailed description
This study will determine the influence of voucher-based CM on reducing smoking (and other drug) use during pregnancy or in post-partum women with children under 1 year of age living with them, or in non-pregnant females who smoke. We are targeting smoking cessation since cigarette use is so prevalent in our service. We will compare a control group to two different voucher-based contingent-reinforcement procedures: one that targets smoking abstinence alone vs. one that offers additional incentives for negative BAL and urinalysis results.
- Conditions
- Tobacco Use Disorder
- Being tested
- Behavior Therapy
- 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.
Behavior TherapyBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2003 (estimated)
- Study startJan 2002
- Primary completionApr 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2/3
- Primary purpose
- Treatment
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Leslie Amass, Ph.D., Principal investigator, Los Angeles Treatment Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00064922
- Sponsor's protocol ID
- NIDA-13638-3
- Other IDs
- R01-13638-3
- Status last verified
- May 2008
- First submitted
- 15 Jul 2003
- Last updated
- 12 Jan 2017
- Results posted
- No
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
- Incentive Programs for Female Substance Abusers Who Smoke
- ClinicalTrials.gov ID
- NCT00064922
- Acronym / sponsor ID
- NIDA-13638-3
- Conditions
- Tobacco Use Disorder
- Keywords
- nicotine dependence
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Jan 2002
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 16 Jul 2003 (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.
The purpose of this study is to examine the effects of incentive programs for the treatment of nicotine dependence in women who have problems with substance dependence.
Detailed description
This study will determine the influence of voucher-based CM on reducing smoking (and other drug) use during pregnancy or in post-partum women with children under 1 year of age living with them, or in non-pregnant females who smoke. We are targeting smoking cessation since cigarette use is so prevalent in our service. We will compare a control group to two different voucher-based contingent-reinforcement procedures: one that targets smoking abstinence alone vs. one that offers additional incentives for negative BAL and urinalysis results.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 15 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Pregnant and or post-partum with at least one child under 1 year old living with them, or non-pregnant, non-post-partum females or previous participant in this study protocol
- Nicotine Dependent as confirmed by DSM-IV checklist
- Current cigarette smoker
- Breath CO reading of at least 8 ppm at the time of the initial study screening
- Current client with the Shields for Families (Shields) treatment programs
Key exclusion criteria (1 listed)
- Non-smoker
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 |
|---|---|---|
| Behavior Therapy | Behavioural | – |
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.
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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.
Leslie Amass, Ph.D. principal investigator
Los Angeles Treatment Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Behavior Therapy in people with Tobacco Use Disorder, run by National Institute on Drug Abuse (NIDA) 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 5 inclusion and 1 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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.