Substance Abuse Disorders Clinical Trial
Official title:
Study of Smoking Abstinence
Background:
- Relapse following cigarette abstinence remains a common problem for smokers who are
attempting to quit. Most research has focused on the acute withdrawal phase that occurs
within the first 48 hours to 1 week after quitting; however, more information is needed on
the experiences of smokers in longer durations of abstinence.
Objectives:
- To study the effects of long-term smoking abstinence.
- To study the effects of cigarette-related cues on craving in longer periods of smoking
abstinence.
Eligibility:
- Individuals at least 18 years of age who are current smokers (at least 10 cigarettes per
day) and who want to quit but are not currently attempting to quit.
Design:
- Participants will be randomly assigned to abstain from all nicotine use for 7, 14, or 35
days. A fourth group of participants will also abstain for 35 days, but will undergo
more testing sessions than the other groups.
- All participants will have an initial orientation session in which they will complete
questionnaires about their smoking habits and will respond to smoking-related cues to
provide information about their cravings.
- Participants will visit the clinic daily during their abstinence period, and provide
urine and breath samples to test for tobacco use. Participants will receive compensation
for every day that they do not use tobacco.
- On the end day of the abstinence period, participants will return to the clinic, provide
urine and breath samples, and undergo testing of their responses to smoking-related
cues. Participants in the fourth group will have these tests on Days 7, 14, and 35 of
abstinence; other participants will have the tests only once, at the end of their
abstinence period.
- After the required abstinence period, participants will enter a 5-day step-down period.
They will continue to report to the clinic for breath and urine testing, and they will
receive payments for abstinence that decrease in value across days.
- After the step-down period, for the final 12 days of the study, participants will report
to the clinic every 3 days to give urine and breath samples and to report the number of
cigarettes smoked.
Background
Relapse following cigarette abstinence remains a common problem for smokers attempting to
quit. Extensive research has focused on the acute withdrawal phase that occurs within the
first 48 hours to one week; however, this study will focus on longer durations of abstinence.
Current clinical wisdom suggests that the rate of relapse decreases as the length of
abstinence increases; however, animal studies indicate that reactivity to drug-related cues
actually increases over time, an effect that has not been studied in humans.
Scientific Goal
To examine the time course of cue reactivity in smokers who have been abstinent for 7, 14,
and 35 days.
Participant Population
A total of up to 420 smokers who are planning to quit in the future, but not right now, and
are willing to undergo a practice quit attempt. Target enrollment will include 50% women and
50% minorities (mostly African-American).
Experimental Design and Methods
Smokers (N=420) will participate in one of 4 groups over a period of 24 to 52 days in
sessions conducted in at the National Institute on Drug Abuse Intramural Research Program at
251 Bayview Blvd, Suite 200, Baltimore, MD 21224, and in a separately approved site, the
Human Behavioral Pharmacology Laboratory (HBPL, L484-496, 5841 S. Maryland Ave., Chicago, IL,
60637). We expect that 190 participants will successfully complete the withdrawal phase (N=50
in groups 1, 2, and 3a, N=40 in group 3b).
Participants will be randomly assigned to abstain from all nicotine use for 7, 14, or 35 days
and participate in one cue-reactivity session on day on the last day of abstinence (groups 1,
2, and 3a; N=50 per condition). The cue-presentation task will involve visual, olfactory, and
tactile cues. After cue presentation, participants will complete the Brief Questionnaire of
Smoking Urges and other standardized mood questionnaires. Physiological responses and
auditory reaction time will be obtained. Group 3b (N=40) will also abstain for 35 days, but
will complete the cue-reactivity task two additional times to provide a within-study
examination of the changes in cue reactivity over long periods of abstinence. On each
laboratory visit, participants will give a urine sample to be tested for cotinine and a
breath sample to be tested for carbon monoxide (CO) to verify abstinence from smoking.
Participants will receive $20 in cash if both tests are negative, and they will accumulate a
further $10 to be paid as a bonus at the end of the abstinence phase. After their required
abstinence period of 7, 14, or 35 days, participants will enter a five-day step-down period
during which they will continue to report to the laboratory for 10 min a day, and they will
receive payments for abstinence in descending value across days. One of the primary outcome
measures in the study is the time to return to smoking, beginning from the last day of
required abstinence. After the step-down period, for the final 12 days of the study,
volunteers will report to the lab every 3 days to give urine and breath samples and to report
the number of cigarettes smoked. Participants will receive $15 for each visit to the
laboratory, and they will receive an end-of-study bonus of $25 for attending all visits. This
money will be paid regardless of whether they abstain from smoking.
Benefits to Participants and/or Society
There is no direct benefit to participants. These studies will provide the basis for future
studies investigating relapse to drug use. They will also shed light on the role of cue
reactivity and impulsivity in relapse. Knowledge about the time course of relapse will
provide important information about the processes underlying drug use and relapse.
Risks to Participants
The risks to participants are minimal. Participants will be healthy cigarette smokers who
will abstain from smoking for varying periods of time and may have increased craving at the
end of the experimental cue-exposure session. They will be given guided relaxation at the end
of the session to reduce craving to pre-session levels and will be fully debriefed following
the study. Some participants experience depression or other adverse symptoms during nicotine
withdrawal. These will be fully described to the participants, and, if the symptoms become
severe, the psychologist/counselor will counsel participants. The only other risks involve
loss of confidentiality from information obtained during screening.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01346514 -
Addiction Housing Case Management for Homeless Veterans
|
N/A |