Cigarette SmokingPhase 2R21NCT00683033
Contingency Management for Smoking in Substance Abusers
A Phase 2 study testing Contingency Management and Brief smoking cessation counseling in people with Cigarette Smoking, run by UConn Health at 1 site in United States.
Trial summary
Patients (N=102) who meet diagnostic criteria for alcohol, cocaine, marijuana, or opiate abuse or dependence will meet with research staff on two days for quit preparation sessions (2 per day). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- Contingency Management and Brief smoking cessation counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Oct 2010
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- current alcohol, cocaine, marijuana, or opiate abuse or dependence
- smoke ≥ 10 cigarettes per day
- expired CO > 8 ppm
- self-reported interest in quitting smoking,
- ≥ 18 years old
- willing to provide names, addresses and phone numbers of individuals to assist in locating the participant for follow-up evaluations,
- English speaking
Who cannot join
- currently receiving behavioral therapy or pharmacotherapy for smoking plan to use pharmacotherapy in this quit attempt
- serious, uncontrolled psychiatric illness (e.g., acute schizophrenia, suicide risk)
- cognitive impairment
- in recovery for pathological gambling
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut Health Center
Farmington, Connecticut, 06030
About this study
Patients (N=102) who meet diagnostic criteria for alcohol, cocaine, marijuana, or opiate abuse or dependence will meet with research staff on two days for quit preparation sessions (2 per day). These sessions include testing a breath sample for evidence of smoking twice each day (separated by at least 5 hours), counseling based on Public Health Service (PHS) guidelines for quitting smoking during the second session each day, and setting a quit date. After these sessions, participants will be randomly assigned to one of two 4-week conditions: (a) standard care or (b) standard care plus prize CM for smoking abstinence with the opportunity to win prizes for submitting samples that meet smoking abstinence criteria (e.g., CO ≤ 6ppm; cotinine ≤ 30ng/mL). Nicotine withdrawal and related measures will be assessed throughout the intervention. Follow-up data will be collected through 6-months post-quit date.
- Conditions
- Cigarette Smoking
- Being tested
- Contingency Management, Brief smoking cessation counseling
- Keywords
- Contingency Management, Cigarette Smoking Cessation, Substance Abusers
- Medical subject headings
- Cigarette Smoking, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency ManagementBehavioural
For 4 weeks starting on the quit date, daily brief (about 5 minutes) counseling based on public health service guidelines for quitting smoking is delivered. Expired carbon monoxide (CO) tests are conducted twice daily and urinary cotinine tests are conducted once each week. Participants earn the opportunity to win prizes for submitting samples that meet smoking abstinence criteria (e.g., CO ≤ 6ppm; cotinine ≤ 30ng/mL).
Brief smoking cessation counselingBehavioural
For 4 weeks starting on the quit date, daily brief (about 5 minutes) counseling based on public health service guidelines for quitting smoking. Expired carbon monoxide tests are conducted twice daily and urinary cotinine tests are conducted once each week.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Brief counseling based on public health service guidelines. Receives: Behavioral: Brief smoking cessation counseling |
| B | Experimental | Brief counseling based on public health service guidelines for quitting smoking plus prize-based contingency management Receives: Behavioral: Contingency Management; Behavioral: Brief smoking cessation counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cigarette smoking abstinence.
Measured: Daily through the 4-week intervention and at follow-up interviews 1, 2, 3, and 6 months following the quit date.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2008 (estimated)
- Study startMay 2008
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette SmokingStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Sheila M Alessi, Ph.D., Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00683033
- Sponsor's protocol ID
- 08-081-2
- Other IDs
- R21DA021836-01A2
- Acronym
- R21
- Status last verified
- Nov 2011
- First submitted
- 14 May 2008
- Last updated
- 21 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contingency Management for Smoking in Substance Abusers
- ClinicalTrials.gov ID
- NCT00683033
- Acronym / sponsor ID
- R21 / 08-081-2
- Conditions
- Cigarette Smoking
- Keywords
- Contingency Management, Cigarette Smoking Cessation, Substance Abusers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- May 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 23 May 2008 (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.
Patients (N=102) who meet diagnostic criteria for alcohol, cocaine, marijuana, or opiate abuse or dependence will meet with research staff on two days for quit preparation sessions (2 per day). These sessions include testing a breath sample for evidence of smoking twice each day (separated by at least 5 hours), counseling based on Public Health Service (PHS) guidelines for quitting smoking during the second session each day, and setting a quit date. After these sessions, participants will be randomly assigned to one of two 4-week conditions: (a) standard care or (b) standard care plus prize CM for smoking abstinence with the opportunity to win prizes for submitting samples that meet smoking abstinence criteria (e.g., CO ≤ 6ppm; cotinine ≤ 30ng/mL). Nicotine withdrawal and related measures will be assessed throughout the intervention. Follow-up data will be collected through 6-months post-quit date.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Behavioral: Brief smoking cessation counselingBrief counseling based on public health service guidelines. |
| B | Experimental | Behavioral: Contingency Management, Behavioral: Brief smoking cessation counselingBrief counseling based on public health service guidelines for quitting smoking plus prize-based contingency management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- current alcohol, cocaine, marijuana, or opiate abuse or dependence
- smoke ≥ 10 cigarettes per day
- expired CO > 8 ppm
- self-reported interest in quitting smoking,
- ≥ 18 years old
Key exclusion criteria (4 listed)
- currently receiving behavioral therapy or pharmacotherapy for smoking plan to use pharmacotherapy in this quit attempt
- serious, uncontrolled psychiatric illness (e.g., acute schizophrenia, suicide risk)
- cognitive impairment
- in recovery for pathological gambling
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 |
|---|---|---|
| Contingency ManagementFor 4 weeks starting on the quit date, daily brief (about 5 minutes) counseling based on public health service guidelines for quitting smoking is delivered. Expired carbon monoxide (CO) tests are conducted twice daily and urinary cotinine tests are conducted once each week. Participants earn the opportunity to win prizes for submitting samples that meet smoking abstinence criteria (e.g., CO ≤ 6ppm; cotinine ≤ 30ng/mL). | Behavioural | B |
| Brief smoking cessation counselingFor 4 weeks starting on the quit date, daily brief (about 5 minutes) counseling based on public health service guidelines for quitting smoking. Expired carbon monoxide tests are conducted twice daily and urinary cotinine tests are conducted once each week. | Behavioural | A, B |
Primary outcome
Cigarette smoking abstinence.
Time frame: Daily through the 4-week intervention and at follow-up interviews 1, 2, 3, and 6 months following the quit date.
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 21 Nov 2011.
Related trials for Cigarette Smoking
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
RecruitingEarly Phase 1
Sensory Tests of Cigarettes for Identification of Flavors in Current Daily Smoking Adults
Cigarette Smoking-Related Carcinoma
Recruiting
Pilot Study of Communication for Dual Users of Cigarettes and E-cigarettes
Tobacco Products, Cigarettes
Active, not recruiting
A Novel Dialectical Behavior Therapy Brief Group Intervention for Cigarette Smoking by Patients With Cancer: An Open Clinical Trial
Smoking Behavior
Recruiting
STEPS: Substance Use Trial of E-cigarettes or Pharmacotherapy for Smoking
Tobacco Use, Substance Use Disorders
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.
Sheila M Alessi, Ph.D. principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Contingency Management and Brief smoking cessation counseling in people with Cigarette Smoking, run by UConn Health 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 7 inclusion and 4 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 21 Nov 2011. 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 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?
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?
Cigarette smoking abstinence. (time frame: Daily through the 4-week intervention and at follow-up interviews 1, 2, 3, and 6 months following the quit date.). It is what the study was designed to measure, not a finding.
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 21 Nov 2011.