Transcript Document

SMOKING CESSATION TREATMENT AT COMMUNITY BASED SUBSTANCE ABUSE REHABILITATION PROGRAMS:
IMPACT ON CIGARETTE SMOKING
Reid MS1, Fallon B2, Sonne S3, Hiott B3, Flammino F1, Nunes E4, Kourniotis E4, Brady R4, Rinaldi P4, Jiang H4, Arfken C5, Pihlgren E5, Giordano L6, Robinson J7, Rotrosen J1
1. NYU School of Medicine and VA New York Harbor Healthcare System, New York, NY. 2. Mt. Sinai Medical Center, New York, NY. 3. Medical University of South Carolina, Charleston, SC. 4. Columbia
University College of Physicians and Surgeons, New York, NY. 5. Wayne State University School of Medicine, Detroit, MI. 6. Duke University, Durham, NC. 7. Nathan Kline Institute, Orangeburg, NY
INTRODUCTION
1
SC
TAU
N=225
N=190
Patients Randomized
Screen Failures
SC
N=153
Early Termination
N=11
Screen Failure Reasons:
TAU
N=72
Completers
N=142
Completers
N=68
Voluntary withdrawal=4
Transferred to other tx.=4
Failed to return to clinic=2
Incarcerated=1
Early Termination
N=4
SC
WK 1-6
SC counseling
TNR (21 mg/day)
WK 7-8
WK 9, 13 & 26
Follow -Up
Screening
Group Cohort
Baseline
Randomization
4 wk, n > 7
SC:TAU (2:1)
WK -1
Figure 3.
Adherence to medication treatment was better than counseling attendance.
Smoking Cessation Counseling
and Patch Use
Substance Abuse Rehabilitation
Study Assessments ( 1/ Week)
Figure 7.
Nicotine withdrawal symptoms also decreased during treatment
(F(1,346)=4.03, p<0.05), as did craving for cigarettes (F(1,175)=5.02, p<0.05)
(Fig. 6), in SC compared to TAU.
Cigarette Craving
SC
25
4
TAU
Counseling
80%
60%
20
15
10
5
WK 9, 13 & 26
-1
Deferred SC
at completion
STUDY PARTICIPANTS
0
0%
Follow –Up
TAU
Non-Methadone Programs
Cigarette Smoking
40%
WK 7-8
0.6
Figure 5.
There was a roughly 75% reduction in the number of cigarettes smoked
per day (F(8,1084)=10.84, p<0.001) in SC compared to TAU.
20%
WK 1-6
0.7
.
Substance Abuse Rehabilitation
BD = Blood Draw, SM = Subjective Measure, EO = Eyes-Open
EEG, EC = Eyes-Closed
Study Assessments
( 1/ Week) EEG
0.8
0.5
Patches
TNR (14 mg/day)
0.9
Methadone Programs
Quit Date
WK -1
SC counseling
Failed to return to clinic=43
Contraindicated medical condition=28
Psychiatric condition needing tx.= 17
In other smoking cessation tx.=16
Failed to meet inclusion criteria=86
Voluntary withdrawal=1
Transferred to other tx.=2
Discharged from clinic=1
100%
1
2
3
4
5
Weeks
6
7
-1
8
Figure 4.
There was a significant main effect of treatment (F(1,1724)=2.81, p<0.01) on smoking
abstinence. There was no gender effect. Smoking abstinence rates in SC at follow-up were
5.5% at Week 13 and 5.7% at Week 26, compared to 0% at Week 13 and 5.2% at Week 26
in TAU (Week 13: c2 (1) =3.395, p=0.065; Week 26: c2 (1)=0.002 p=0.963).
1
2
3
4
5
Weeks
6
7
8
TAU
30%
20%
10%
0%
CO levels (ppm)
SC
4
5
Weeks
6
1
-1
7
8
9
Total number of weeks abstinent during treatment was positively associated with counseling
adherence (r = 0.306, p<0.001) and, at a weaker level, with nicotine patch adherence (r = 0.152,
p<0.05).
1
2
3
4
5
6
7
8
9
Figure 8.
There was no difference in substance abuse abstinence rates between SC
and TAU over the course of treatment (F(1,1632)=0.00, p=0.955) and no
main effect of treatment (F(1,1633)=0.82, p=0.444).
Primary Substance of Abuse:
Abstinence Defined by Self-Report and (-) UDS/BA
100%
SC
90%
TAU
20
80%
70%
15
60%
50%
10
40%
5
30%
SC
20%
TAU
10%
0
3
2
Exhaled CO
40%
2
3
Weeks
25
1
TAU
9
Figure 6.
There was a modest decrease in exhaled CO, significant by main effect of treatment
(F(1,751)=22.64, p<0.001), in SC compared to TAU.
50%
-1
SC
0
Smoking Abstinence
OUTCOME MEASURES
Primary Outcome Measure: 7-day point prevalence of smoking abstinence,
assessed at each study visit and defined as a self-report of no smoking confirmed
by exhaled breath CO level < 10 ppm. Missing data was imputed as nonabstinent. A GLMM model analyzed weekly smoking abstinence status during
treatment (Week –1 through Week 9) as a function of treatment, time, and the
treatment by time interaction with subject and site as random variables. Analysis of
gender effect on smoking abstinence, performed in SC only due to negligible
abstinence rates in TAU, was done using the same approach.
Secondary Smoking Outcome Measures: cigarettes smoked/day, exhaled CO
levels, self-reported nicotine withdrawal and craving, were analyzed using similar
mixed effect models (MEM) with baseline values of the outcome variables included
in the model when applicable. Weekly compliance rates with smoking cessation
counseling attendance and nicotine patches were compared between methadone
and non-methadone study sites using MEM. Compliance was compared with
smoking abstinence analyzed by Pearson’s correlation coefficients.
Secondary Substance Abuse Outcome Measures: Each individual’s primary
substance of abuse, determined based on DSM-IV criteria and confirmed by
clinical interview, was evaluated. 7-day point prevalence abstinence from primary
substance of abuse, defined as self-report of no use over the last week confirmed
by urine drug screen or breath alcohol tests negative for that substance, was
analyzed using an MEM approach as described above.
Retention in the study and substance abuse treatment was tested using log-rank
test on time to dropout.
Study Retention
Patients Screened
WST: Craving Subscore
STUDY DESIGN
N=415
Percent abstinent
A. Study Sites: 7 community based treatment programs (CTP) affiliated with
the CTN, including 5 methadone maintenance treatment programs and 2
outpatient drug and alcohol rehabilitation clinics. Participating CTPs did not
have existing smoking cessation treatment programs on site.
B. Primary Eligibility Criteria:
a. Smoke at least 10 cigarettes per day,
b. Interested in quitting smoking,
c. Current drug or alcohol dependence (methadone maintained patients in
remission were also eligible)
d. Enrolled in their respective substance abuse treatment programs for at
least 30 days
e. Psychiatrically stable
f. No contraindicated medical conditions; eg. skin disease, allergies to TNR,
hypertension
C. Randomization: Eligible subjects were randomly assigned on a 2:1 ratio
to 1) substance abuse treatment-as-usual plus smoking cessation treatment
(SC) or 2) substance abuse treatment-as-usual (TAU). Assignment to
treatment was done with cohorts; when at least 7 participants where eligible
for randomization.
D. Treatment:
Counseling: Smoking cessation counseling was done in closed group
format, based on the Mood Management and Cognitive Behavioral Therapy
for Smoking Cessation manual from the Habit Abatement Clinic, University of
California, San Francisco (Munoz et al., 1988; Hall et al., 1994) which had
been tailored for substance abuse treatment patients. Counseling included 9
group smoking cessation counseling sessions beginning one week prior to,
and continuing for 6 weeks after, the Target Quit Date (Day 1 in the protocol
schedule).
Medication: Smoking cessation pharmacotherapy consisted of open-label,
transdermal nicotine patches (NicoDerm CQ). Participants began
medication on the Target Quit Date and continued through the end of Week 8
(Day 56), starting with 21 mg/day patches for Weeks 1-6 and then 14 mg/day
patches for Weeks 7-8. Participants unable to tolerate the 21mg/day patch
were allowed to have a dose reduction to the 14 mg/day patch.
In the TAU condition, participants were offered deferred smoking cessation
treatment.
EXPERIMENTAL DESIGN
Figure 2.
Study retention did not differ by treatment groups (log-rank test, p=0.28), or program type.
Disposition of Study Patients
cigarettes/day
METHODS
RESULTS
Survival Proportion (Wk 9)
Most (70-90%) of patients in treatment for drug or alcohol dependence are cigarette smokers. Such concurrent
smoking is responsible for substantial medical problems, contributes to mortality among substance dependent
patients, and is associated with greater levels of substance abuse (Budney et al., 1993; Stark and Campbell, 1993;
Hurt et al., 1996). However, patients in substance abuse treatment are interested and willing to enroll in smoking
cessation treatment (Irving et al., 1994; Clarke et al., 2001; Joseph et al., 2004), and a number of clinical trials have
demonstrated that smoking cessation treatment is effective among substance dependent patients, resulting in modest
abstinence rates (for rev. and ref. see Prochaska et al., 2004). The existing clinical trials of treatment for co-occurring
nicotine dependence are limited in several respects, being confined to one or a few sites, often university-affiliated,
and many were based in inpatient or residential treatment programs where the impact on substance abuse outcomes
cannot be fully evaluated. This suggests the need for a clinical trial to test the effectiveness of smoking cessation
treatment across multiple community-based outpatient substance abuse treatment programs, and to also examine its
impact on the outcome of concurrent drug and alcohol problems. We therefore conducted a randomized trial of
nicotine replacement therapy (NicoDerm CQ) plus group cognitive behavioral counseling compared to treatment as
usual across multiple community-based outpatient substance abuse treatment programs within the National Drug
Abuse Treatment, Clinical Trials Network (CTN).
-1
1
2
3
4
5
Weeks
6
7
8
9
0%
-1
1
2
3
4
5
Weeks
6
7
8
9
On average, 85% of smoking abstinent subjects and 55% of smoking nonabstinent subjects were abstinent from their primary substance of abuse.
However, smoking abstinence was not a statistically significant predictor of
substance abuse abstinence (F(1,874)=2.00, p=0.157), due to the small
number of smoke free study participants.
DISCUSSION
Cigarette smoking among drug and alcohol dependent patients is of high public health significance because of its
prevalence, chronicity, and serious adverse health consequences. The present study showed that a combination of
nicotine patch and cognitive behavioral/mood management counseling was feasible to implement in community based,
outpatient substance abuse treatment settings, produced low abstinence rates but strong reductions in smoking
behavior, and did not worsen outcome of the primary drug or alcohol problems. Compliance with treatment was critical
to obtaining quit smoking rates. These results are in line with those seen in other moderate intensity smoking cessation
trials conducted with this population (Prochaska et al., 2004). Future research should examine more powerful
medications for smoking cessation, and behavioral interventions that can be integrated in a flexible fashion into existing
substance abuse treatment minimizing barriers to participation.
References
Budney AJ, Higgins ST, Hughes JR, Bickel WK (1993) Nicotine and caffeine use in cocaine-dependent individuals. J. Subst. Abuse 5, 117-130.
Clarke JG, Stein MD, McGarry, KA, Gogineni A (2001) Interest in smoking cessation among injection drug users. Am. J. Addict. 10, 159-166.
Hurt RD, Offord KP, Crogan IT, Gomez-Dahl L, Kottke TE, Morse RM, Melton III, J (1996) Mortality following inpatient addictions treatment: Role of tobacco
use in a community-based cohort. JAMA 275, 1097-1103.
Irving LM, Seidner AL, Burling TA, Thomas RG, Brenner GF (1994) Drug and alcohol abuse inpatient’s attitudes about smoking cessation. J. Subst. Abuse
Treat. 6, 267-278.
Joseph AM, Lexau B, Willenbring M, Nugent S, Nelson D (2004a) Factors associated with readiness to stop smoking among patients in treatment for alcohol
use disorder. Am J. Addiction 13, 405-417.
Prochaska JJ, Delucchi K, Hall SM (2004) A meta-analysis of smoking cessation interventions with individuals in substance abuse treatment or recovery. J.
Consult. Clin. Psychol. 72, 1144-1156.
Stark MJ, Campbell BK (1993) Drug use and cigarette smoking in applicants for drug abuse treatment. J. Subst. Abuse 5, 175-181.
SUPPORT
Cooperative agreements from the National Institute on Drug Abuse supported the design, implementation, and analyses within the NIDA CTN: New York
Node (U10 DA13046), Long Island Node (U10 DA13035), South Carolina Node (U10 DA13727), North Carolina Node (U10 DA13711), Pacific Node (U10
DA13045), Florida Node (U10 DA13720), Great Lakes Node (U10 DA13710). We wish to acknowledge the support and participation of the clinical and
research staff in the NIDA-CTN-0009 participating programs. Mt. Sinai Hospital, Narcotics Rehabilitation Center, New York , NY, Bridge Plaza Narco
Freedom, New York, NY, St. Luke’s-Roosevelt Hospital Methadone and Alcohol Treatment Programs, New York, NY, Center for Drug-Free Living, Orlando,
FL, Psychiatry and Behavioral Medical Professionals, Detroit, MI, Coastal Horizons Center, Wilmington, NC, Daymark Recovery Services, Concord, NC,
Behavioral Health Services of Pickens County, Pickens, SC, Chelsea Arbor Treatment Center, Ann Arbor, MI, Spectrum Programs, Inc., Miami, FL, Matrix
Institute, Los Angeles, CA, Tarzana Treatment Centers, Tarzana, CA