Cognitive behavioral therapy and the nicotine transdermal patch for dual nicotine and cannabis dependence: a pilot study.
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SUBMITTER: Hill KP
PROVIDER: S-EPMC3641687 | biostudies-literature | 2013 May-Jun
REPOSITORIES: biostudies-literature
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Cognitive behavioral therapy and the nicotine transdermal patch for dual nicotine and cannabis dependence: a pilot study.
Hill Kevin P KP Toto Lindsay H LH Lukas Scott E SE Weiss Roger D RD Trksak George H GH Rodolico John M JM Greenfield Shelly F SF
The American journal on addictions 20130501 3
<h4>Background and objectives</h4>We assessed the feasibility of a new cognitive behavioral therapy (CBT) manual, plus transdermal patch nicotine replacement therapy (NRT), to treat co-occurring nicotine and cannabis dependence.<h4>Method</h4>Seven of 12 (58.3%) adults with DSM-IV diagnoses of both nicotine and cannabis dependence completed 10 weeks of individual CBT and NRT.<h4>Results</h4>Participants smoked 12.6 ± 4.9 tobacco cigarettes per day at baseline, which was reduced to 2.1 ± 4.2 at t ...[more]
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Project description:BACKGROUND:The current lack of pharmacological treatments for cannabis use disorder (CUD) warrants novel approaches and further investigation of promising pharmacotherapy. We previously showed that nabiximols (27 mg/ml ?9-tetrahydrocannabinol (THC)/ 25 mg/ml cannabidiol (CBD), Sativex®) can decrease cannabis withdrawal symptoms. Here, we assessed in a pilot study the tolerability and safety of self-titrated nabiximols vs. placebo among 40 treatment-seeking cannabis-dependent participants. METHODS:Subjects participated in a double blind randomized clinical trial, with as-needed nabiximols up to 113.4 mg THC/105 mg CBD or placebo daily for 12 weeks, concurrently with Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT). Primary outcome measures were tolerability and abstinence, secondary outcome measures were days and amount of cannabis use, withdrawal, and craving scores. Participants received up to CDN$ 855 in compensation for their time. RESULTS:Medication was well tolerated and no serious adverse events (SAEs) were observed. Rates of adverse events did not differ between treatment arms (F1,39 = 0.205, NS). There was no significant change in abstinence rates at trial end. Participants were not able to differentiate between subjective effects associated with nabiximols or placebo treatments (F1,40 = 0.585, NS). Cannabis use was reduced in the nabiximols (70.5%) and placebo groups (42.6%). Nabiximols reduced cannabis craving but no significant differences between the nabiximols and placebo groups were observed on withdrawal scores. CONCLUSIONS:Nabiximols in combination with MET/CBT was well tolerated and allowed for reduction of cannabis use. Future clinical trials should explore the potential of high doses of nabiximols for cannabis dependence.
| S-EPMC5791962 | biostudies-literature
Project description:Cannabis use disorder (CUD) is the most common illicit substance use disorder and individuals with CUD have high rates of comorbid anxiety disorders. Comorbidity between CUD and anxiety disorders is of public health relevance given that although motivation enhancement therapy (MET) combined with cognitive-behavioral therapy (CBT) is an efficacious intervention for CUD, outcomes are worse for patients with elevated anxiety. The current study tested the acceptability and efficacy of the integration of a transdiagnostic anxiety CBT (i.e., treatment of patients with any anxiety disorder) with MET-CBT (integrated cannabis and anxiety reduction treatment, or ICART) for CUD compared to MET-CBT alone. Treatment-seeking cannabis users (56.4% male, Mage = 23.2, 63.3% non-Hispanic White) with CUD and at least one comorbid anxiety disorder were randomly assigned to ICART (n = 27) or MET-CBT (n = 28). Patients in the ICART condition attended significantly more treatment sessions than those in the MET-CBT condition. Patients in the ICART condition were more likely to be abstinent post-treatment than those in MET-CBT. Further, treatment produced decreases in cannabis use and related problems. Notably, therapy type did not moderate the impact of treatment on frequency of use and related problems. Together, these data suggest that ICART may be at least as efficacious as a gold-standard psychosocial CUD treatment, MET-CBT, for a difficult-to-treat subpopulation of cannabis users.
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Project description:BackgroundTobacco smoking is associated with a reduced risk of developing sarcoidosis, and we previously reported that nicotine normalizes immune responses to environmental antigens in patients with active pulmonary sarcoidosis. The effects of nicotine on the progression of pulmonary sarcoidosis are unknown.Research questionIs nicotine treatment well tolerated, and will it improve lung function in patients with active pulmonary sarcoidosis?Study design and methodsWith local institutional review board approval, a randomized, double-blind, controlled pilot trial was conducted of daily nicotine transdermal patch treatment (21 mg daily) or placebo patch use for 24 weeks. The Ohio State University Wexner Medical Center and Cleveland Clinic enrolled 50 consecutive subjects aged ≥ 18 years with active pulmonary sarcoidosis, based on symptoms (ie, dyspnea, cough) and objective radiographic evidence of infiltrates consistent with nonfibrotic lung disease. Each study group was compared at 26 weeks based on repeated measures of FVC, FEV1, quantitative lung texture score based on CT texture analysis, Fatigue Assessment Score (FAS), St. George's Respiratory Questionnaire (SGRQ), and the Sarcoidosis Assessment Tool.ResultsNicotine treatment was associated with a clinically significant, approximately 2.1% (70 mL) improvement in FVC from baseline to 26 weeks. FVC decreased by a similar amount (2.2%) in the placebo group, with a net increase of 140 mL (95% CI, 10-260) when comparing nicotine vs placebo groups at 26 weeks. FEV1 and FAS improved marginally in the nicotine-treated group, compared with those on placebo. No improvement was observed in lung texture score, FAS, St. George's Respiratory Questionnaire score, or the Sarcoidosis Assessment Tool. There were no reported serious adverse events or evidence of nicotine addiction.InterpretationNicotine treatment was well tolerated in patients with active pulmonary sarcoidosis, and the preliminary findings of this pilot study suggest that it may reduce disease progression, based on FVC.Clinical trial registrationClinicalTrials.gov; No.: NCT02265874; URL: www.clinicaltrials.gov.
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Project description:Extended use of combined pharmacotherapies to treat tobacco dependence may increase smoking abstinence; few studies have examined their effectiveness. The objective of this study was to evaluate smoking abstinence with standard nicotine patch (NRT), extended use of combined formulations of nicotine replacement therapy (NRT+), or varenicline (VR).A total of 737 smokers, including those with medical and psychiatric comorbidities, were randomly assigned to one of the above three treatment conditions. The NRT group received 10 weeks of patches (21 mg daily maximum); the NRT+ group received patches (35 mg daily maximum) and gum or inhaler for up to 22 weeks; and the VR group received 1 mg twice daily for up to 24 weeks (22 weeks post target quit date). All participants also received six standardized 15-minute smoking cessation counseling sessions by nurses experienced in tobacco dependence treatment. The primary outcome was carbon monoxide-confirmed continuous abstinence rates (CAR) from weeks 5-52. Secondary outcomes were: CAR from weeks 5-10 and 5-22, and carbon monoxide-confirmed 7-day point prevalence (7PP) at weeks 10, 22, and 52. Adjusted and unadjusted logistic regression analyses were conducted using intention-to-treat procedures.The CARs for weeks 5-52 were 10.0 %, 12.4 %, and 15.3 % in the NRT, NRT+, and VR groups, respectively; no group differences were observed. Results with 7PP showed that VR was superior to NRT at week 52 (odds ratio (OR), 1.84; 97.5 % Confidence Interval (CI), 1.04-3.26) in the adjusted intention-to-treat analysis. Those in the VR group had higher CAR at weeks 5-22 (OR, 2.01; CI, 1.20-3.36) than those in the NRT group. Results with 7PP revealed that both NRT+ (OR, 1.72; CI, 1.04-2.85) and VR (OR, 1.96; CI, 1.20-3.23) were more effective than NRT at 22 weeks. As compared to NRT monotherapy, NRT+ and VR produced significant increases in CAR for weeks 5-10 (OR, 1.52; CI, 1.00-2.30 and OR, 1.58; CI, 1.04-2.39, respectively); results were similar, but somewhat stronger, when 7PP was used at 10 weeks (OR, 1.57; CI, 1.03-2.41 and OR, 1.79; CI, 1.17-2.73, respectively). All medications were well tolerated, but participants in the VR group experienced more fatigue, digestive symptoms (e.g., nausea, diarrhea), and sleep-related concerns (e.g., abnormal dreams, insomnia), but less dermatologic symptoms than those in the NRT or NRT+ groups. The frequency of serious adverse events did not differ between groups.Flexible and combination NRT and varenicline enhance success in the early phases of quitting. Varenicline improves abstinence in the medium term; however, there is no clear evidence that either varenicline or flexible, dual-form NRT increase quit rates in the long-term when compared to NRT monotherapy.ClinicalTrials.gov Identifier: NCT01623505 ; Retrospectively registered on July 13, 2011.
| S-EPMC4884360 | biostudies-literature
Project description:BackgroundVarenicline, a new treatment for smoking cessation, has demonstrated significantly greater efficacy over placebo and sustained release bupropion (bupropion SR). A study was undertaken to compare a 12-week standard regimen of varenicline with a 10-week standard regimen of transdermal nicotine replacement therapy (NRT) for smoking cessation.MethodsIn this 52-week, open-label, randomised, multicentre, phase 3 trial conducted in Belgium, France, The Netherlands, UK and USA, participants were randomly assigned (1:1) to receive varenicline uptitrated to 1 mg twice daily for 12 weeks or transdermal NRT (21 mg/day reducing to 7 mg/day) for 10 weeks. Non-treatment follow-up continued to week 52. The primary outcome was the biochemically confirmed (exhaled carbon monoxide < or = 10 ppm) self-reported continuous abstinence rate (CAR) for the last 4 weeks of the treatment period in participants who had taken at least one dose of treatment. Secondary outcomes included CAR from the last 4 weeks of treatment through weeks 24 and 52, and measures of craving, withdrawal and smoking satisfaction.ResultsA total of 376 and 370 participants assigned to varenicline and NRT, respectively, were eligible for analysis. The CAR for the last 4 weeks of treatment was significantly greater for varenicline (55.9%) than NRT (43.2%; OR 1.70, 95% CI 1.26 to 2.28, p<0.001). The week 52 CAR (NRT, weeks 8-52; varenicline, weeks 9-52) was 26.1% for varenicline and 20.3% for NRT (OR 1.40, 95% CI 0.99 to 1.99, p = 0.056). Varenicline significantly reduced craving (p<0.001), withdrawal symptoms (p<0.001) and smoking satisfaction (p<0.001) compared with NRT. The most frequent adverse event was nausea (varenicline, 37.2%; NRT, 9.7%).ConclusionsThe outcomes of this trial established that abstinence from smoking was greater and craving, withdrawal symptoms and smoking satisfaction were less at the end of treatment with varenicline than with transdermal NRT.Trial registration numberNCT00143325.
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| S-EPMC2905892 | biostudies-literature
Project description:Background and aimsThe United States Food and Drug Administration has proposed regulation to require that cigarettes contain very low nicotine content (VLNC). In contrast, reducing the number of cigarettes per day (CPD) is the most common current method to reduce nicotine. This trial aims to explore whether gradually transitioning to VLNC cigarettes plus nicotine patch or reducing CPD plus nicotine patch is more effective at decreasing nicotine dependence.DesignA two-arm, individually randomized open-label trial.SettingCommunity setting, Vermont, USA.ParticipantsSixty-eight adult daily smokers (40% female) of ≥ 10 cigarettes/day who were not planning to quit in the next 30 days.InterventionsAll participants smoked study cigarettes with a nicotine yield similar to most commercial cigarettes ad libitum for 1 week (baseline). Participants then gradually reduced to 70, 35, 15 and 3% of baseline nicotine over 4 weeks by either (a) transitioning to lower nicotine content cigarettes (n = 36) or (b) reducing the number of full nicotine cigarettes (n = 32). All participants received nicotine patches.MeasurementsThe primary outcome was change in nicotine dependence assessed at baseline and weekly during the intervention with the Nicotine Dependence Syndrome Scale.FindingsDependence declined over time for both VLNC and CPD participants, but declined more for VLNC (mean decrease in Z-score of 1.0) than CPD (mean decrease in Z-score of 0.5) participants over time (interaction P = 0.018).ConclusionsTransitioning to very low nicotine content cigarettes reduced nicotine dependence over a 4-week period to a greater extent than reducing cigarettes per day when both conditions were aided by nicotine patch.
| S-EPMC6682423 | biostudies-literature
Project description:Tobacco dependence is a chronic, relapsing condition that may require extended treatment.To assess whether extended-duration transdermal nicotine therapy increases abstinence from tobacco more than standard-duration therapy in adult smokers.Parallel randomized, placebo-controlled trial from September 2004 to February 2008. Participants and all research personnel except the database manager were blinded to randomization. (ClinicalTrials.gov registration number: NCT00364156)Academic center.568 adult smokers.In an unstratified small block-randomization scheme, participants were randomly assigned to standard therapy (Nicoderm CQ [GlaxoSmithKline, Research Triangle Park, North Carolina], 21 mg, for 8 weeks and placebo for 16 weeks) or extended therapy (Nicoderm CQ, 21 mg, for 24 weeks).The primary outcome was biochemically confirmed point-prevalence abstinence at weeks 24 and 52. Secondary outcomes were continuous and prolonged abstinence, lapse and recovery events, cost per additional quitter, and side effects and adherence.At week 24, extended therapy produced higher rates of point-prevalence abstinence (31.6% vs. 20.3%; odds ratio, 1.81 [95% CI, 1.23 to 2.66]; P = 0.002), prolonged abstinence (41.5% vs. 26.9%; odds ratio, 1.97 [CI, 1.38 to 2.82]; P = 0.001), and continuous abstinence (19.2% vs. 12.6%; odds ratio, 1.64 [CI, 1.04 to 2.60]; P = 0.032) versus standard therapy. Extended therapy reduced the risk for lapse (hazard ratio, 0.77 [CI, 0.63 to 0.95]; P = 0.013) and increased the chances of recovery from lapses (hazard ratio, 1.47 [CI, 1.17 to 1.84]; P = 0.001). Time to relapse was slower with extended versus standard therapy (hazard ratio, 0.50 [CI, 0.35 to 0.73]; P < 0.001). At week 52, extended therapy produced higher quit rates for prolonged abstinence only (P = 0.027). No differences in side effects and adverse events between groups were found at the extended-treatment assessment.The generalizability of the findings may be limited because participants were smokers without medical comorbid conditions who were seeking treatment, and differences in adherence across treatment groups were detected.Transdermal nicotine for 24 weeks increased biochemically confirmed point-prevalence abstinence and continuous abstinence at week 24, reduced the risk for smoking lapses, and increased the likelihood of recovery to abstinence after a lapse compared with 8 weeks of transdermal nicotine therapy.National Institutes of Health.
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Project description:PURPOSE:We evaluate if cigarette smoking and/or nicotine dependence predicts cannabis use disorder symptoms among adolescent and young adult cannabis users and whether the relationships differ based on frequency of cannabis use. METHODS:Data were drawn from seven annual surveys of the NSDUH to include adolescents and young adults (age 12-21) who reported using cannabis at least once in the past 30?days (n?=?21,928). Cannabis use frequency trends in the association between cigarette smoking, nicotine dependence and cannabis use disorder symptoms were assessed using Varying Coefficient Models (VCM's). RESULTS:Over half of current cannabis users also smoked cigarettes in the past 30?days (54.7% SE 0.48). Cigarette smoking in the past 30?days was associated with earlier onset of cannabis use, more frequent cannabis use and a larger number of cannabis use disorder symptoms compared to those who did not smoke cigarettes. After statistical control for socio-demographic characteristics and other substance use behaviors, nicotine dependence but not cigarette smoking quantity or frequency was positively and significantly associated with each of the cannabis use disorder symptoms as well as the total number of cannabis symptoms endorsed. Higher nicotine dependence scores were consistently associated with the cannabis use disorder symptoms across all levels of cannabis use from 1?day used (past month) to daily cannabis use, though the relationship was strongest among infrequent cannabis users. CONCLUSION:Prevention and treatment efforts should consider cigarette smoking comorbidity when addressing the increasing proportion of the US population that uses cannabis.
| S-EPMC5959804 | biostudies-literature
Project description:BackgroundCo-use of tobacco and cannabis and dual use of cigarettes and e-cigarettes are very common among young adults. However, it is unclear whether co-use of cigarettes, e-cigarettes, and/or cannabis is associated with higher levels of nicotine dependence than cigarette-only use. We investigated the relationship between cigarette/nicotine dependence and co-use of tobacco and cannabis among 4 groups of cigarette smokers aged 18-35: cigarette-only smokers, cigarette-e-cigarette (CIG-ECIG) co-users, cigarette-cannabis (CIG-CAN) co-users, and cigarette-e-cigarette-cannabis (CIG-ECIG-CAN) co-users.MethodsData were from a 2018 cross-sectional survey based on a national convenience sample of smokers aged 18-35 (n = 315). Cigarette/nicotine dependence was measured by the Fagerstrom Test of Nicotine Dependence (FTND) and e-cigarette dependence was measured by the Penn State E-cigarette Dependence Index. Bivariate analyses examined sociodemographic and tobacco/other substance use characteristics by co-use status and multivariable linear regression assessed the relationship between co-use and nicotine dependence.ResultsIn the sample, 27.6% were cigarette-only smokers, 24.8% were CIG-ECIG, 27.6% were CIG-CAN, and 20.0% were CIG-ECIG-CAN co-users. Significant differences were observed in sociodemographic and tobacco/other substance use characteristics by co-use status. E-cigarette co-users had low e-cigarette dependence, but moderate FTND scores. In adjusted analyses, only CIG-ECIG co-use was associated with higher FTND scores compared to cigarette-only smoking. However, CIG-ECIG and CIG-ECIG-CAN co-use were associated with higher FTND scores compared to CIG-CAN co-use.ConclusionsCo-use of cigarettes and e-cigarettes was associated with greater nicotine dependence among smokers aged 18-35. Additional research is needed to understand the underlying mechanisms of these relationships and inform prevention efforts.
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