CLINICAL TRIAL

QUIT for Tobacco Dependence

1 Prior Treatment
Relapsed
Recruiting · 18+ · All Sexes · Boston, MA

This study is evaluating whether a specific type of therapy may help smokers living with HIV quit smoking.

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About the trial for Tobacco Dependence

Eligible Conditions
Depression · Anxiety · Smoking, Cessation · Tobacco Use Disorder · Smoking, Cigarette · Smoking · HIV Infections · Depressive Disorder · Acquired Immunodeficiency Syndrome · Anxiety Disorders · Human Immunodeficiency Virus (HIV) Infections · Nicotine Dependence

Treatment Groups

This trial involves 2 different treatments. QUIT is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
QUIT
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Time-Matched Control (TM)
BEHAVIORAL

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Tobacco Dependence or one of the other 11 conditions listed above. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Daily Smoker
Motivated to quit smoking
18-79 years old
HIV-positive
Capability and willingness to give written informed consent
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Time frame: 6-Month Follow-Up (approximately 6-months post quit date)
Screening: ~3 weeks
Treatment: Varies
Reporting: Time frame: 6-Month Follow-Up (approximately 6-months post quit date)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Time frame: 6-Month Follow-Up (approximately 6-months post quit date).
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether QUIT will improve 2 primary outcomes in patients with Tobacco Dependence. Measurement will happen over the course of Time frame: 1-Month Follow-Up (end of treatment/approximately 1-month post quit date).

Short-Term Point Prevalence Smoking Abstinence
TIME FRAME: 1-MONTH FOLLOW-UP (END OF TREATMENT/APPROXIMATELY 1-MONTH POST QUIT DATE)
Biologically verified 7-day point prevalence abstinence (PPA). Using the timeline follow-back method (TLFB), participants will self-report the last time they smoked. TLFB results will be biologically verified with carbon monoxide analysis of breath samples (if stated abstinence is between 24 hours and 2 weeks), saliva cotinine (if stated abstinence is 2+ weeks and participant is currently using nicotine replacement therapy), or urine anabasine (if stated abstinence is 2+ weeks and participant is not currently using nicotine replacement therapy).
TIME FRAME: 1-MONTH FOLLOW-UP (END OF TREATMENT/APPROXIMATELY 1-MONTH POST QUIT DATE)
Long-Term Point Prevalence Smoking Abstinence
TIME FRAME: 6-MONTH FOLLOW-UP (APPROXIMATELY 6-MONTHS POST QUIT DATE)
Biologically verified 7-day point prevalence abstinence (PPA). Using the timeline follow-back method (TLFB), participants will self-report the last time they smoked. TLFB results will be biologically verified with carbon monoxide analysis of breath samples (if stated abstinence is between 24 hours and 2 weeks), saliva cotinine (if stated abstinence is 2+ weeks and participant is currently using nicotine replacement therapy), or urine anabasine (if stated abstinence is 2+ weeks and participant is not currently using nicotine replacement therapy).
TIME FRAME: 6-MONTH FOLLOW-UP (APPROXIMATELY 6-MONTHS POST QUIT DATE)

Who is running the study

Principal Investigator
C. O.
Prof. Conall O'Cleirigh, Associate Professor of Psychology
Massachusetts General Hospital

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get tobacco dependence a year in the United States?

Around 25 million Americans have tried to quit smoking in the past year, but more than half restart smoking within 2 months. About 70% of smokers quit without help, a strategy that can be successful in smoking cessation.

Anonymous Patient Answer

What causes tobacco dependence?

Tobacco dependence is a complicated disorder of repeated exposure to tobacco that is associated mainly with substance use disorders and social problems. Long-term nicotine use may alter brain circuitry critical for motivation and reinforcement, while acute or sustained use affects the prefrontal cortex, hypothalamus, limbic system, mesocorticolimbic dopamine system, and mesolimbic glutamate system. These changes may have important implications for treatment of tobacco dependence.

Anonymous Patient Answer

What is tobacco dependence?

Results from a recent clinical trial shows for the first time that there is a positive association between the development of tobacco dependence and the occurrence of depression, while, conversely, tobacco dependence is associated with a higher risk of developing depression.

Anonymous Patient Answer

What are the signs of tobacco dependence?

Tobacco use has the potential to cause significant distress to the tobacco user, family member, and family system, and to negatively affect a wide range of other psychological attributes in both smokers and non-smokers. These adverse effects may have substantial long-term consequences to the health of tobacco users; therefore, smokers may experience increased morbidity and medical management cost through their use of tobacco.

Anonymous Patient Answer

What are common treatments for tobacco dependence?

Medications are used to treat tobacco dependence, but behavioral changes are paramount in its treatment. Self-help programs and counseling are also used to treat tobacco dependence. A combination of these approaches seem to be especially successful.

Anonymous Patient Answer

Can tobacco dependence be cured?

Individuals are not able to be cured from tobacco dependence. If you have it or if you are dependent on it, there are few options around. If your dependence can be reduced, then you can get a bit of better lifestyle and enjoy the life. But if unfortunately, your dependence on cigarettes and tobacco will increase, then there is no chance that you can control it.

Anonymous Patient Answer

What are the common side effects of quit?

A good deal of information is known about the pharmacokinetics of tokacin in smokers. Its effect on the CNS in non-smokers is unknown, as are its cardiovascular side effects in this special patient.

Anonymous Patient Answer

Is quit safe for people?

Patients' smoking status, in particular their cravings, has important effects on the response to NRT. When this was explored, craving had a significant effect on the success rate of NRT. Thus, clinicians should inform smokers with a great deal of urgency not to quit.

Anonymous Patient Answer

What is the latest research for tobacco dependence?

Researchers at different institutions have made new discoveries. For instance, one study reported a breakthrough in understanding brain development in tobacco dependent rats. More recent research has shown the potential of new treatments, such as neurophysiology, and the role that hormones play in the development of tobacco dependence. Other areas of recent discovery include how smokers manage the devastating effects of tobacco dependence as well as the interaction of nicotine with specific types of neurons, all within the context of neural networks and the brain's ventral tegmental area. More information on the latest studies in addiction research can be found in the “Tobacco dependence – Current research” section.

Anonymous Patient Answer

Have there been other clinical trials involving quit?

Most smokers(2-4) are willing to seek out medical help such as medication to help them with quitting, and they are still able to quit or lessen the effects of their addiction for the duration of the study (e.g. up to 12 weeks)?. Of those who participated in a quit trial, >50% reported being healthier or feeling better (e.g. 'being in better shape and having healthier thoughts and habits') and the likelihood of achieving their quitting goals was also greater.

Anonymous Patient Answer

How serious can tobacco dependence be?

While dependence is often an indicator of more serious illness, the symptoms of tobacco dependence may not always be debilitating. Patients who present with severe and disabling symptoms should be evaluated with respect to the possibility of [alcohol dependence or co-occurring non-adherence disorders and/or co-occurring health conditions that could be causing symptoms] and encouraged to seek further help or seek treatment. In general, clinicians and patients need to be aware that the severity of tobacco dependence is not synonymous with the severity of illness. Clinicians should work together and communicate to assure the best care for their patients. Patients who are struggling with serious and debilitating symptomatology do not always consult their physicians for help.

Anonymous Patient Answer

What is the average age someone gets tobacco dependence?

The average age of smokers getting diagnostically diagnosed with tobacco dependence is around 54 years (5 years younger than what was reported in early reports).

Anonymous Patient Answer
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