Low incidence of adverse events following varenicline initiation among opioid dependent smokers with comorbid psychiatric illness

Abstract

Background Most drug treatment patients smoke cigarettes, yet few data exist on the prevalence and outcomes of varenicline treatment among smokers with comorbid substance use and psychiatric disorders. Methods We reviewed all patient charts of opioid-dependent smokers prescribed varenicline between May 2006 and December 2009 in two urban methadone clinics that also provide on-site medical and psychiatric care. We assessed prevalence, adverse events, and effectiveness of varenicline treatment in this cohort. Results We identified 575 smokers among 690 patients (83.3%), and assessed 82 courses of varenicline treatment prescribed to 70 smokers. Both cardiovascular risk factors and psychiatric illness were highly prevalent among those prescribed varenicline: hypertension, 51%; hyperlipidemia, 23%; diabetes, 20%; depression, 53%; anxiety, 30%; psychotic disorders, 10%; bipolar disorder, 8.6%. Of 82 varenicline courses, nine (11%) were discontinued due to adverse events and two due to depressive symptoms. One patient initiated new psychiatric medications within six months of initiating varenicline, but did not discontinue varenicline. There were no reports of suicidal ideation, agitation prompting clinical intervention, or psychiatric hospitalization. There were no incident cardiac or vascular events within six months of varenicline prescription. Some (8.6%) varenicline-treated smokers quit smoking, and cessation was significantly associated with varenicline treatment duration. Conclusions Despite substantial comorbidity, opioid-dependent smokers receiving integrated substance abuse, medical and psychiatric care had few documented adverse events with varenicline treatment. Methadone patients will likely experience little harm and a great deal of benefit from treatment with varenicline for smoking cessation.

Varenicline efficacy and safety among methadone maintained smokers: a randomized placebo-controlled trial

“…A more limited evidence base supports the safety of varenicline among substance abuse treatment patients. In a cohort of 70 opioid dependent patients prescribed varenicline, few had documented adverse psychiatric events (17). In one randomized trial of varenicline among methadone-maintained smokers, there were no adverse psychiatric events observed with 12 weeks of varenicline (10).…”

“…Despite an FDA boxed warning about varenicline-associated psychiatric risks, observational data among methadone patients (17) and growing research on varenicline among persons with psychiatric co-morbidity (18–23) suggest that varenicline is associated with minimal adverse psychiatric events.…”

“…Reasons for the scant provision of smoking cessation alternatives in substance abuse treatment programs are multi-faceted [12][13][14][15][16], and include limited treatment capacity, unfounded fears that smoking cessation treatment might jeopardize recovery, and particularly regarding varenicline, concerns about psychiatric risks for patients with substantial psychiatric comorbidity. Despite a Food and Drug Administration (FDA) boxed warning about varenicline-associated psychiatric risks, observational data among methadone patients [17] and growing research on varenicline among people with psychiatric comorbidity [18][19][20][21][22][23] suggest that varenicline is associated with minimal adverse psychiatric events.…”

Smoking cessation treatment among office-based buprenorphine treatment patients

“…If smoking status was documented following cessation medication prescription, but not documented in subsequent visits, the last observation was carried forward. Although this approach may not capture relapse following initial cessation or delayed tobacco cessation, similar methods have been used in prior studies (Nahvi, Wu, Richter, Bernstein, & Arnsten, 2013). …”

Treatment of Comorbid Tobacco Addiction in Substance Use and Psychiatric Disorders

“…Many studies suggest the utility of NRTs, bupropion SR, and varenicline combined with behavioral interventions as safe and effective for smoking cessation in individuals with opioid use disorders [57][58][59]. However, cessation rates in opioid dependent smokers are very low (0 %-11 %) [60], and more effective treatments based on an increased understanding of tobacco-opioid agonist maintenance interactions are warranted.…”