Naltrexone + Bupropion for Smoking Cessation in Schizophrenia
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: The University of Texas Health Science Center, Houston
Must not be taking: Naltrexone, Bupropion
Disqualifiers: Suicidal ideation, Alcohol use disorder, Epilepsy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The purpose of this study is to assess the feasibility and safety of injectable naltrexone (NTX;380 mg) in conjunction with oral bupropion (BUP; 450 mg daily)NTX-BUP administration among individuals with schizophrenia spectrum disorders that smoke cigarettes and to evaluate change on smoking-related measures and symptoms of schizophrenia.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but you cannot participate if you are taking medications that should not be used with naltrexone or bupropion.
Is the drug combination of Naltrexone and Bupropion effective for helping people with schizophrenia quit smoking?
Research shows that Bupropion, when combined with nicotine replacement therapy and cognitive behavioral therapy, can help people with schizophrenia reduce or quit smoking. Studies found that Bupropion led to higher rates of smoking reduction and abstinence without worsening schizophrenia symptoms.
12345Is the combination of Naltrexone and Bupropion safe for smoking cessation in people with schizophrenia?
Bupropion is generally well tolerated for smoking cessation, with the most common side effect being insomnia. However, there is a small risk of seizures (0.1%) and serious allergic reactions (0.12%). There are concerns about psychiatric disturbances, but these may be influenced by pre-existing conditions.
678910How does the drug Naltrexone + Bupropion for smoking cessation in schizophrenia differ from other treatments?
This drug combination is unique because it combines bupropion, which helps reduce smoking by affecting brain chemicals like dopamine and norepinephrine, with naltrexone, which is typically used to treat alcohol and opioid dependence. This combination may offer a novel approach by targeting both the chemical and behavioral aspects of smoking addiction in people with schizophrenia.
1341112Eligibility Criteria
This trial is for adults with schizophrenia who smoke cigarettes and are interested in quitting. Participants should be stable on their antipsychotic medication, not currently pregnant or breastfeeding, and without a history of seizures or opioid use.Inclusion Criteria
My schizophrenia is currently under control.
Obtain an Evaluation to Sign Consent (ESC) score above 10
I am not pregnant, breastfeeding, and agree to use birth control and undergo pregnancy tests during the study.
+4 more
Exclusion Criteria
Currently enrolled in treatment for tobacco use
Have suicidal or homicidal ideation requiring immediate attention
I am not on medications that interfere with naltrexone or bupropion.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive injectable naltrexone and oral bupropion for 3 weeks
3 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests the combination of injectable Naltrexone (380 mg) and oral Bupropion (450 mg daily) to see if it helps people with schizophrenia quit smoking. It will also look at how this combo affects their schizophrenia symptoms.
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment2 Interventions
Bupropion is already approved in United States, European Union, Canada, Australia for the following indications:
🇺🇸 Approved in United States as Wellbutrin for:
- Major depressive disorder
- Seasonal affective disorder
- Smoking cessation
🇪🇺 Approved in European Union as Wellbutrin for:
- Major depressive disorder
- Seasonal affective disorder
- Smoking cessation
🇨🇦 Approved in Canada as Zyban for:
- Smoking cessation
🇦🇺 Approved in Australia as Wellbutrin for:
- Major depressive disorder
- Seasonal affective disorder
- Smoking cessation
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The University of Texas health Science Center at HoustonHouston, TX
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Who Is Running the Clinical Trial?
The University of Texas Health Science Center, HoustonLead Sponsor
References
A 12-week double-blind, placebo-controlled study of bupropion sr added to high-dose dual nicotine replacement therapy for smoking cessation or reduction in schizophrenia. [2022]The objective of this study was to examine whether there is a benefit of adding bupropion SR to high-dose combination nicotine replacement therapy (NRT) and weekly group cognitive behavioral therapy (CBT) for smoking reduction or cessation in schizophrenia. Fifty-one adult smokers with schizophrenia were randomly assigned to a 12-week trial of bupropion SR 300 mg/d or placebo added to transdermal nicotine patch, nicotine polacrilex gum, and CBT. The treatment goal was smoking cessation. The primary outcome measure was biochemically confirmed 7-day point-prevalence of 50% to 100% smoking reduction at week 12. Secondary outcomes were biochemically confirmed tobacco abstinence and change from baseline in expired air carbon monoxide (CO) and psychiatric symptoms. Subjects on bupropion + NRT had a greater rate of 50% to 100% smoking reduction at weeks 12 (60% vs. 31%; P = 0.036) and 24, a lower expired air CO in the treatment and follow-up periods, (F = 13.8; P
A double-blind placebo-controlled trial of bupropion sustained-release for smoking cessation in schizophrenia. [2022]The objective of this study was to examine the efficacy of bupropion for smoking cessation in patients with schizophrenia. Adults with schizophrenia who smoked more than 10 cigarettes per day and wished to try to quit smoking were recruited from community mental health centers, enrolled in a 12-week group cognitive behavioral therapy intervention, and randomly assigned to receive either bupropion sustained-release 300 mg/d or identical placebo. Fifty-three adults, 25 on bupropion and 28 on placebo, were randomized, completed at least 1 postbaseline assessment and were included in the analysis. The primary outcome measures were 7-day point prevalence abstinence in the week after the quit date (week 4) and at the end of the intervention (week 12). Subjects in the bupropion group were significantly more likely to be abstinent for the week after the quit date (36% [9/25] vs. 7% [2/28], P = 0.016) and at end of the intervention (16% [4/25] vs. 0%, P = 0.043). Subjects in the bupropion group also had a higher rate of 4-week continuous abstinence (weeks 8-12) (16% [4/25] vs. 0%, P = 0.043) and a longer duration of abstinence (4.2 [3.2] weeks vs. 1.8 [0.96] weeks, t = 2.30, P = 0.037). The effect of bupropion did not persist after discontinuation of treatment. Subjects in the bupropion group had no worsening of clinical symptoms and had a trend toward improvement in depressive and negative symptoms. We conclude that bupropion does not worsen clinical symptoms of schizophrenia and is modestly effective for smoking cessation in patients with schizophrenia. The relapse rate is high after treatment discontinuation.
A placebo-controlled trial of bupropion combined with nicotine patch for smoking cessation in schizophrenia. [2022]Individuals with schizophrenia smoke at higher rates (58%-88%) than the general population (approximately 22%), and have difficulty quitting. We determined whether the combination of sustained-release (SR) bupropion (BUP) with the transdermal nicotine patch (TNP) was well-tolerated and superior to placebo (PLO)+TNP for smoking cessation in schizophrenia.
A pilot trial of bupropion added to cognitive behavioral therapy for smoking cessation in schizophrenia. [2022]The purpose of this study was to investigate the effect of adding sustained-release (SR) bupropion to cognitive behavioral therapy (CBT) on smoking behavior and stability of psychiatric symptoms in patients with schizophrenia. We conducted a 3-month, double-blind, placebo-controlled trial of bupropion SR, 150 mg/day, added to a concurrent CBT program with 3-month follow-up in 19 stable outpatients with schizophrenia who wanted to quit smoking. Eighteen subjects completed the trial. Bupropion treatment was associated with significantly greater reduction in smoking, as measured by self-report verified by expired-air carbon monoxide (6/9 subjects, 66%), than placebo (1/9 subjects, 11%) during the 3-month active treatment period and the 3-month follow-up period. One subject in the bupropion group (11%) and no subjects in the placebo group achieved sustained tobacco abstinence for the 6-month trial. Bupropion treatment was associated with improvement in negative symptoms and greater stability of psychotic and depressive symptoms, compared with placebo, during the quit attempt. Subjects in the bupropion group experienced significant weight loss, compared with those on placebo during the smoking cessation attempt. These data suggest that bupropion SR, 150 mg/day, combined with CBT, may facilitate smoking reduction in patients with schizophrenia while stabilizing psychiatric symptoms during a quit attempt.
Pharmacotherapy for smoking cessation in schizophrenia: a systematic review. [2021]Introduction: Rates of tobacco smoking are high in people with schizophrenia with greater difficulty of quitting smoking compared to the general population, which also relate to the increased cardiovascular and cancer risks in this co-occurring disorder. Therefore, effective smoking cessation pharmacotherapies addressing tobacco co-morbidity are imperative.Areas covered: In this review, the authors performed an extensive systematic electronic literature review examining the efficacy and safety of first-line pharmacotherapies for smoking cessation, including varenicline, sustained-release bupropion, and nicotine replacement therapies (NRT) using continuous abstinence rates over 10-12-week periods in smokers with schizophrenia. Twelve trials reporting smoking cessation outcomes using interventions in schizophrenia were included and risk ratio (RR) was used.Expert opinion: Our findings support the efficacy and safety of first-line pharmacotherapies for the treatment of tobacco use disorder in smokers with schizophrenia. Further research on the long-term effectiveness and safety of these agents in community samples is warranted. Smoking cessation pharmacotherapies may warrant the consideration of the emerging use of electronic nicotine delivery systems while neuromodulation techniques also offer promise.
Efficacy and Safety of Pharmacotherapeutic Smoking Cessation Aids in Schizophrenia Spectrum Disorders: Subgroup Analysis of EAGLES. [2023]This study aimed to evaluate the efficacy and safety of varenicline, bupropion, and nicotine replacement therapy (NRT) among smokers with schizophrenia spectrum disorders in post hoc analyses of Evaluating Adverse Events in a Global Smoking Cessation Study data.
Mental health status of varenicline and bupropion users during a quit attempt compared to current smokers, other quitters, and non-smokers. [2022]Varenicline and bupropion are commonly prescribed non-nicotine containing smoking cessation agents. Post-marketing reports suggest an increased incidence of psychiatric disturbances associated with varenicline and bupropion. However, pre-existing psychiatric disorders may confound the association between these smoking cessation agents and psychiatric disturbances. We compared the mental health status of individuals using varenicline or bupropion to that of people quitting without medication, current smokers, and non-smokers while controlling for pre-existing conditions.
Efficacy and safety of bupropion SR for smoking cessation: data from clinical trials and five years of postmarketing experience. [2013]Bupropion SR was introduced for smoking cessation in the US in 1997. This review assesses the efficacy and safety of bupropion SR for treatment of tobacco dependence based on data from clinical trials and five years of postmarketing experience. Through June 2001, there were approximately 32 million patient exposures to bupropion (9 million for smoking cessation) in clinical practice, and more than 8000 patients have been studied in clinical trials for tobacco dependence. In clinical trials, bupropion SR was more effective than placebo at improving initial and long-term abstinence rates and preventing relapse. Bupropion SR is generally well tolerated. The most common adverse event in clinical trials or clinical practice is insomnia, which can also be a symptom of nicotine withdrawal. The two main risks of treatment with bupropion SR are major motor seizure and hypersensitivity reaction. Clinical trials data suggest that the incidence of seizure is approximately 0.1%, and that of serious cases of hypersensitivity approximately 0.12%. Benefit-risk assessment, assuming a 30% one-year quit rate demonstrates that for every 10,000 smokers treated with bupropion SR, 19 lives are saved and 86 cases of smoking-attributed morbidity are averted in a five-year period while the risk of experiencing one of the two potentially serious adverse events during treatment is 0.22%. These data further establish both the efficacy and safety of bupropion SR and its use in preventing the adverse health effects of chronic tobacco use.
Treatment With Bupropion and Varenicline for Smoking Cessation and the Risk of Acute Cardiovascular Events and Injuries: a Swedish Case-Crossover Study. [2022]Bupropion and varenicline are non-nicotine medications used for smoking cessation that mitigate craving and withdrawal symptoms. We aim to investigate whether these drugs increase the risk of selected acute adverse outcomes when used in medical practice.
Suitability of bupropion SR for nicotine-dependent smokers: problems in a practice setting. [2017]Bupropion SR (Zyban) has been shown in randomized controlled trials to be an efficacious pharmacological aid for smoking cessation; however, recent reports have raised serious concerns about the breadth of its applicability without complications or contraindications.
[Acute psychotic disorders related to bupropion: review of the literature]. [2013]Bupropion, or amfebutamone, is an atypical antidepressant also used during tobacco cessation. From a structural standpoint, it resembles amphetamine drugs with psychostimulant effects, and endogenous monoamines. From a pharmacological standpoint, bupropion, and two of its most important active metabolites, inhibit dopamine and norepinephrine reuptake. It has recently been discovered that bupropion may act as a non-competitive cholinergic nicotinic receptor antagonist, and that it may inhibit the activation of reward systems triggered by nicotine. Buproprion's efficacy as a smoking cessation aid has been demonstrated by numerous clinical trials that have compared its effects with those of placebo and other nicotinic substitutes. In 2001, buproprion SR received marketing authorization in France as a smoking cessation aid, under the name ZYBAN®. Tobacco addiction indeed remains a major public health issue. Among patients with psychiatric conditions, chronic tobacco consumption is frequent. The development of non-nicotinic drugs may therefore enhance therapeutic possibilities. However, the psychotropic effects of these molecules should be taken into account. We have recently reported the case of a patient with schizoaffective disorder, who presented two acute bupropion-induced psychotic episodes. We have also undertaken an exhaustive bibliographical research on this subject. The aim of the present study is to present the information available to us, in order to suggest aetiopathogenic hypotheses and therapeutic proposals.
[Tobacco and schizophrenia: therapeutic aspects]. [2020]Although patients with have low motivations to quit smoking, smoking cessation treatment can be effective for these patients. Patients schizophrenia who achieve significant smoking reduction during a treatment intervention can at least maintain that level of reduction at 2 years. Cigarette smoking by patients with frequently goes unaddressed, contributing to excess mortality in this population. Behavioural interventions improve smoking cessation in schizophrenia patients. Nicotine replacement can substantially reduce withdrawal symptoms. Bupropion enhances smoking abstinence rates. Bupropion is well-tolerated and safe for use in schizophrenia patients: bupropion does not worsen clinical symptoms of schizophrenia. Atypical antipsychotics may reduce smoking consumption in schizophrenia patients, in particular clozapine. Atypical antipsychotic medication, in combination with the nicotine transdermal patch, significantly enhance the rate of smoking cessation. Interactions between smoking and antipsychotic medication - Smoking increases the metabolism of the antipsychotic medications by inducing the cytochrome P450 1A2 isoform. Smoking lowers the blood levels of typical or atypical antipsychotic medication, in particular haloperidol, chlorpromazine, olanzapine and clozapine. -Abstinence can increase many psychotropics' blood levels. Accordingly, smoking appears to reduce neuroleptic-induced parkinsonism. In contrast, smoking is a risk factor for tardive dyskinesia, independent of neuroleptic exposure.