Nicotine DependencePhase 2/3ROSENCT00497068
Tobacco Use in Opioid Agonist Treated Pregnant Women
A Phase 2/3 study testing tobacco abstinent contingent and non-contingent in people with Nicotine Dependence, run by Johns Hopkins University at 1 site in United States.
Trial summary
The primary objective of the proposed study is to evaluate the efficacy of tobacco abstinence-contingent voucher incentives versus non-tobacco abstinence-contingent incentives for reducing or eliminating tobacco use during pregnancy in methadone treated women. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- tobacco abstinent contingent and non-contingent
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Jun 2010
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Confirmed pregnancy
- Treatment entry at or before 31 weeks EGA
- Expected to enter drug-free outpatient modality at CAP
- Placed on methadone pharmacotherapy
- Nicotine dependent
- Sufficient literacy and understanding for assessment procedures
Show all 10Show fewer
- Expected availability for study duration (e.g., complete inpatient stay)
- Able and willing to provide informed consent
- At least 18 years of age
- Confirmed smoker of 10 or more cigarettes
Who cannot join
- Not pregnant
- EGA of 32 weeks or greater
- 17 years of age or younger
- Undergoing detoxification (non-methadone treatment)
- Unable to provide informed consent
- Currently receiving nicotine replacement products (NRT)
- Current diagnosis of alcohol or benzodiazepine dependence
- Severe medical or psychiatric concomitant conditions that would interfere with treatment or require extended hospitalization.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center, Center for Addiction and Pregnancy
Baltimore, Maryland, 21224
About this study
The primary objective of the proposed study is to evaluate the efficacy of tobacco abstinence-contingent voucher incentives versus non-tobacco abstinence-contingent incentives for reducing or eliminating tobacco use during pregnancy in methadone treated women. In addition, the impact that this intervention has in reducing the incidence and severity of methadone associated neonatal abstinence syndrome will also be examined.
- Conditions
- Nicotine Dependence
- Being tested
- tobacco abstinent contingent, non-contingent, control
- Keywords
- smoking, pregnancy, neonatal abstinence syndrome
- Medical subject headings
- Tobacco Use Disorder, Smoking, Neonatal Abstinence Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tobacco abstinent contingentBehavioural
Participants receive vouchers wiht monetary rewards for providing breath samples that show tobacco smoking abstinence
non-contingentBehavioural
Participants receive vouchers regardless of tobacco use status
controlBehavioural
this group receives no vouchers
| Study group | Role | What they receive |
|---|---|---|
| tobacco abstinent contingent voucher | Experimental | Tobacco abstinent contingent voucher condition Receives: Behavioral: tobacco abstinent contingent |
| non-contingent | Experimental | Participants receive vouchers non-contingent upon tobacco use status Receives: Behavioral: non-contingent |
| no voucher | Other | This is the standard care intervention Receives: Behavioral: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of tobacco-free urine samples submitted and Neonatal Abstinence Score
Measured: from treatment entry until 6 weeks post-partum
Secondary outcomes (1)
tobacco use measures • treatment compliance• Neonatal measures include:Birth parameters
Measured: from treatment entry to 6 weeks posrt-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2007 (estimated)
- Study startJan 2005
- Primary completionSep 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 Johns Hopkins 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Hendree E. Jones, Johns Hopkins University
- Investigators
- Hendree E Jones, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00497068
- Sponsor's protocol ID
- R01DA012403
- Other IDs
- R01DA012403, DPMCDA
- Acronym
- ROSE
- Status last verified
- Mar 2013
- First submitted
- 5 Jul 2007
- Last updated
- 5 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Tuten M, Svikis DS, Keyser-Marcus L, O'Grady KE, Jones HE. Lessons learned from a randomized trial of fixed and escalating contingency management schedules in opioid-dependent pregnant women. Am J Drug Alcohol Abuse. 2012 Jul;38(4):286-92. doi: 10.3109/00952990.2011.643977. Epub 2012 Feb 22.
PubMed 22352784
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
- Tobacco Use in Opioid Agonist Treated Pregnant Women
- ClinicalTrials.gov ID
- NCT00497068
- Acronym / sponsor ID
- ROSE / R01DA012403
- Conditions
- Nicotine Dependence
- Keywords
- smoking, pregnancy, neonatal abstinence syndrome
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2005
- Primary completion
- Sep 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 6 Jul 2007 (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 primary objective of the proposed study is to evaluate the efficacy of tobacco abstinence-contingent voucher incentives versus non-tobacco abstinence-contingent incentives for reducing or eliminating tobacco use during pregnancy in methadone treated women. In addition, the impact that this intervention has in reducing the incidence and severity of methadone associated neonatal abstinence syndrome will also be examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tobacco abstinent contingent voucher | Experimental | Behavioral: tobacco abstinent contingentTobacco abstinent contingent voucher condition |
| non-contingent | Experimental | Behavioral: non-contingentParticipants receive vouchers non-contingent upon tobacco use status |
| no voucher | Other | Behavioral: controlThis is the standard care intervention |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Confirmed pregnancy
- Treatment entry at or before 31 weeks EGA
- Expected to enter drug-free outpatient modality at CAP
- Placed on methadone pharmacotherapy
- Nicotine dependent
Key exclusion criteria (8 listed)
- Not pregnant
- EGA of 32 weeks or greater
- 17 years of age or younger
- Undergoing detoxification (non-methadone treatment)
- Unable to provide informed consent
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 |
|---|---|---|
| tobacco abstinent contingentParticipants receive vouchers wiht monetary rewards for providing breath samples that show tobacco smoking abstinence | Behavioural | tobacco abstinent contingent voucher |
| non-contingentParticipants receive vouchers regardless of tobacco use status | Behavioural | non-contingent |
| controlthis group receives no vouchers | Behavioural | no voucher |
Primary outcome
Percent of tobacco-free urine samples submitted and Neonatal Abstinence Score
Time frame: from treatment entry until 6 weeks post-partum
1 secondary outcome
tobacco use measures • treatment compliance• Neonatal measures include:Birth parameters
Time frame: from treatment entry to 6 weeks posrt-partum
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 5 Mar 2013.
- Derived from this study: PubMed 22352784Tuten M, Svikis DS, Keyser-Marcus L, O'Grady KE, Jones HE. Lessons learned from a randomized trial of fixed and escalating contingency management schedules in opioid-dependent pregnant women. Am J Drug Alcohol Abuse. 2012 Jul;38(4):286-92. doi: 10.3109/00952990.2011.643977. Epub 2012 Feb 22.
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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.
Hendree E Jones, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing tobacco abstinent contingent and non-contingent in people with Nicotine Dependence, run by Johns Hopkins 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 10 inclusion and 8 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. 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.
What does the primary outcome measure?
Percent of tobacco-free urine samples submitted and Neonatal Abstinence Score (time frame: from treatment entry until 6 weeks post-partum). 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 NCT00497068, 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.