During a 1-week screening period, potential participants will be required to complete a detoxification program, including stopping all cocaine and alcohol use. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Urine collection was monitored by temperature checks. FOIA Narcolepsy is caused by dysfunction of a family of wakefulness-promoting and sleep-suppressing peptides, the orexins, whose neurons are activated by modafinil. Modafinil has reduced cocaine subjective effects and cocaine self-administration in human laboratory trials and has reduced cocaine use in cocaine dependent patients in some clinical trials. Lives a commutable distance from the TRC and agrees to attend all research visits including follow-up visits. Medications known to have contraindicated interactions with modafinil oral, Technivie Oral (ombitasvir-paritaprevir-ritonavir oral). Kelly Spratt made substantial contributions to the data collection and preparation of the manuscript. Diabetes Metab Syndr Obes. Eligible treatment-seeking, cocaine-dependent subjects entered a 4-week baseline period (Phase I) with high-value abstinence contingent vouchers and two motivational interviewing sessions, followed by a 12-week medication trial (Phase II) with random assignment stratified on Phase I abstinence status to (1) modafinil (400mg/d), (2) levodopa/carbidopa (800/200mg/d), (3) naltrexone (50mg/d), or (4) placebo. Schmitz JM, Green CE, Stotts AL, Lindsay JA, Rathnayaka NS, Grabowski J, Moeller FG. A 2013 meta-analysis of 6 studies and 910 individuals with major depressive disorder or bipolar depression found that augmentation of modafinil was effective in reducing acute depressive episodes. 2015 Oct 1; 155: 105110. For ED treatment, PlushCare physicians can prescribe brand-name or generic Viagra, Cialis, Levitra, and Stendra. Both are 200mg modafinil, but people say Modalert about 16 hours and Modvigil about 12. It's used alongside exercise and a balanced diet to help certain adults lose weight. In the Anderson trial, the subgroup of cocaine dependent subjects without a current or lifetime history of alcohol dependence represented 59% of the overall sample (Anderson et al., 2009). Subject meets current DSM-IV diagnosis of any other clinically significant psychiatric disorder that will interfere with study participation. Select a version's Submitted Date link to see a rendering of the study for that version. The 2011 Impact Factor score for Biological Psychiatry is 8.283. At each visit, a urine test and breathalyzer will be used to screen for the presence of alcohol and drugs. Drug information provided by: Merative, Micromedex US Brand Name. Blood will be drawn for laboratory tests, and urine tests will be used to screen for the presence of drugs and alcohol. 2012 trial (400 mg) but more efficacious than the lower dose (200 mg). For obstructive sleep apnea, modafinil is indicated to improve wakefulness in . Please remove one or more studies before adding more. Testing the feasibility of using a prerandomization, abstinence-induction protocol, we screened three candidate medications to explore treatment response in patients who did, or did not, achieve abstinence during an extended baseline phase. Modafinil treated subjects were more likely to rate themselves as very much improved. During the 13-week treatment phase, participants will be randomly assigned to receive modafinil, naltrexone, a combination of modafinil and naltrexone, or placebo. modafinil oral brand names and other generic formulations include: Provigil Oral. Modafinil has demonstrated efficacy in the subgroup of cocaine dependent patients without comorbid alcohol dependence in three separate trials, including the current trial (Anderson et al., 2009; Dackis et al., 2005). Grant BF, Harford TC. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Modafinil also enhances glutamateneurotransmission (Touret et al., 1994). Careers. Cocaine pharmacotherapy trials are often confounded by considerable variability in baseline cocaine-use levels, obscuring possible medication efficacy. McLellan AT, Kushner H, Metzger D, Peters R, Smith I, Grissom G, Pettinati H, Argeriou M. The fifth edition of the Addiction Severity Index. Federal government websites often end in .gov or .mil. UNABLE TO MATCH INTERACTION DETAILS FOR 166972 TO 16962; at MNI.Service.Models.ServiceProviders.ArticleType.RxDrugCheckerServiceProvider.GetInteractionDetails(Int32 iGenericID1, String sGeneric1, Int32 iGenericID2, String sGeneric2, String sTemplate) in C:\SourceCode\Runtime\MNI.NET-NEW-PROD\MNI.Services.Prod\MNI.Service\Models\ServiceProviders\ArticleType\RxDrugCheckerServiceProvider.cs:line 124. Drug Alcohol Depend. A two-phased screening paradigm for evaluating candidate medications for cocaine cessation or relapse prevention: modafinil, levodopa-carbidopa, naltrexone. Medications known to have contraindicated interactions with modafinil oral home drug interactions checker contraindicated interactions for modafinil oral Brand Names Include: Provigil Oral All generic drug interactions for modafinil oral (lists will include brand and generic names): 47 serious drug interactions 459 significant drug interactions This interesting new study suggests that, if you are impulsive, modafinil may help your self-control, commented Dr. John Krystal, Editor of Biological Psychiatry. Additional outcome measures included cocaine craving measured by the Brief Substance Craving Scale and global improvement measured by the Clinical Global Impression Scale (CGI). Reports new study in Biological PsychiatryPhiladelphia, PA, February 1, 2013 Poor impulse control contributes to ones inability to control the consumption of rewarding substances, like food, alcohol, and other drugs. Accessibility Past research has shown that individuals who are addicted to both cocaine and alcohol typically respond poorly to conventional substance abuse treatment. In addition, participants will meet weekly with a nurse practitioner, who will dispense study medications, monitor adverse events, and evaluate the participant's clinical status. Participants will also undergo a physical exam and an electrocardiogram. PMC 2012 trial, 64% of subjects assigned to modafinil completed the trial compared to 83% in the current trial. Ma L, Cunningham KA, Anastasio NC, Bjork JM, Taylor BA, Arias AJ, Riley BP, Snyder AD, Moeller FG. both are manufactured in India .. In the past 30 days, used no less than $200-worth of cocaine and meets the following drinking criteria as measured by the Timeline Followback (TLFB) (Sobell, 1995): To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Does modafinil interact with my other drugs? Severe physical or medical illnesses such as AIDS, active hepatitis, significant hepatocellular injury as evidenced by elevated total bilirubin levels (>1.3 mg/dl),or elevated levels (over 4.5x normal) of aspartate aminotransferase (AST), and serum glutamic-pyruvic transaminase (SGPT) after the required 3 days of abstinence. Excessive sleepiness due to narcolepsy, shift work disorder, or obstructive sleep apnea Armodafinil (Nuvigil) dosage forms tablet 50mg 150mg 200mg 250mg Typical dosing for armodafinil (Nuvigil) Narcolepsy and obstructive sleep apnea: The recommended dose is 150 mg to 250 mg by mouth once daily in the morning. The purpose of this study is to evaluate the effectiveness of modafinil and naltrexone, alone and in combination, at reducing drug and alcohol use in individuals addicted to cocaine and alcohol. In the 30 days prior to study entry, subjects used no less than $200-worth of cocaine. The study nurse practitioner, and the subjects themselves, rated overall improvement weekly using the Clinical Global Impression Scale (CGI; Guy, 1976). Attendance at clinic and completing assessments were reinforced using fishbowl contingency management. Provigil; Descriptions. Results. Corresponding author: Kyle M. Kampman, University of Pennsylvania Treatment Research Center, 3900 Chestnut Street, Philadelphia, PA 19104, Phone: 215 222 3200 x 109, Fax: 215 386 6770: The publisher's final edited version of this article is available at, This was a double blind placebo controlled trial of modafinil for cocaine dependence, It involved 94 subjects treated with 300 mg of modafinil or placebo daily for 8 weeks, Modafinil treated subjects were more likely to achieve cocaine abstinence, Modafinil treated subjects were more likely to report very low levels of cocaine craving, Modafinil treated subjects were more likely to rate themselves very much improved, modafinil, cocaine, alcohol, clinical trial, placebo. sharing sensitive information, make sure youre on a federal Schmaal explained further, Most importantly, the study showed that modafinil had a positive effect in patients with high initial levels of impulsivity, whereas modafinil had a detrimental effect in patients with low initial levels of impulsivity. Modafinil has been shown to increase dopaminergic neurotransmission by blocking the dopamine transporter and this may account for its ability to reduce cocaine withdrawal symptoms and reduce the high associated with cocaine use (Volkow et al., 2009). 8600 Rockville Pike At each visit, a urine test and breathalyzer will be used to screen for the . The https:// ensures that you are connecting to the Waklert and modalert are literally both manufactured by the same people.. and modvigil is also from India. 2023 Apr 10:2023.04.09.536189. doi: 10.1101/2023.04.09.536189. 1 Cocaine-use outcomes for levodopa and naltrexone treatment differed as a function of Phase I abstinence status, with both medications producing benefit in nonabstinent but not baseline-abstinent subjects. Both medications can also cause dry mouth, indigestion (dyspepsia), and anxiety. to investigate the effects of modafinil on impulsivity in alcohol dependent patients and healthy controls. Medication adherence was measured only by pill count and thus may not be accurate. Is female and tests positive on a pregnancy test, is contemplating pregnancy in the next 6 months, is nursing, or is not using an effective contraceptive method (if relevant). In a double blind, placebo-controlled pilot trial of modafinil involving 62 cocaine-dependent subjects, modafinil-treated subjects submitted significantly more cocaine metabolite-free urine samples compared to placebo-treated subjects (42% vs. 22%). aDepartment of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3900 Chestnut Street, Philadelphia, PA, USA, 19104, bDepartment of Medicine, Perelman School of Medicine, University of Pennsylvania, 3400 Spruce Street, Philadelphia, PA, USA, 19104, cCenter for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, 3400 Spruce Street, Philadelphia, PA, USA, 19104. His disclosures of financial and conflicts of interests are available here.About Biological PsychiatryBiological Psychiatry is the official journal of the Society of Biological Psychiatry, whose purpose is to promote excellence in scientific research and education in fields that investigate the nature, causes, mechanisms and treatments of disorders of thought, emotion, or behavior. Somoza E, Dyrenforth S, Goldsmith J, Mezinskis J, Cohen M. In search of a universal drug craving scale., Annual Meeting of the American Psychiatric Association, Miami FLA. Touret M, Sallanon-Moulin M, Fages C, Roudier V, Didier-Bazes M, Roussel B, Tardy M, Jouvet M. Effects of modafinil-induced wakefulness on glutamine synthetase regulation in the rat brain. The prescription is electronically sent to the pharmacy of your choice in as little as 24 hours. Baker D, McFarland K, Lake R, Shen H, Toda S, Kalivas P. N-acetyl cysteine-induced blockade of cocaine-induced reinstatement. CM = contingency management., Moderator effects of baseline abstinence, Moderator effects of baseline abstinence status. Federal government websites often end in .gov or .mil. Print Save Modafinil Interactions There are 458 drugs known to interact with modafinil, along with 9 disease interactions, and 2 alcohol/food interactions. Cookie Notice The CSSA composite measures overall cocaine withdrawal symptoms. Slightly more than ninety percent of prescribed study medication was consumed, based on pill counts. Bookshelf All authors declare that they have no conflicts of interest. However, among subjects who were not also alcohol dependent, both doses of modafinil were superior to placebo for promoting abstinence from cocaine (Anderson et al., 2009). The placebo group was more likely to report psychiatric problems (p=0.03, OR=2.75, 95% CI = (1.33, 5.68) based on a dichotomized version of the psychiatric composite score (=0 vs >0). Post marketing side effects of Modafinil reported include: aggression. the contents by NLM or the National Institutes of Health. Male and females, 18 years of age or older. UNABLE TO DISPLAY ANY INTERACTIONS AT THIS TIME. Cocaine withdrawal symptoms and initial urine toxicology results predict treatment attrition in outpatient cocaine dependence treatment. Diagram of study design. Study visits will take place twice a week. Modafinil has reduced cocaine use among cocaine dependent subjects in clinical trials. 299 0 obj <> endobj Contingency management and levodopa-carbidopa for cocaine treatment: a comparison of three behavioral targets. Schmitz JM, Rathnayaka N, Green CE, Moeller FG, Dougherty AE, Grabowski J. Severe. The researchers also measured participants underlying brain activity while they completed a stop signal task designed to measure impulsive behavior. Sitemap. Subjects were treatment-seeking cocaine users recruited at the University of Pennsylvania Treatment Research Center (TRC). hbbd``b` @ H0 @e #.F? When all missing weeks were imputed as non-abstinent weeks, the corresponding estimated odds ratio was 2.23 (95% CI = (0.97, 5.09)), and the effect was not significant (GEE Score Test Chi-square(1)=3.41, p=0.06). In this 16-week trial, cocaine dependent subjects were treated with modafinil 200 mg daily, modafinil 400 mg daily, or placebo. It is an eugeroic medication, which means it is wakefulness-promoting agent. The Therapeutic Potential of Medications with Varying Degrees of Abuse Liability in the Treatment of Substance Use Disorders. DeVito EE, Poling J, Babuscio T, Nich C, Carroll KM, Sofuoglu M. Drug Alcohol Depend Rep. 2022 Mar;2:100032. doi: 10.1016/j.dadr.2022.100032. severe tingling, numbness and pain. . Naltrexone is a medication that is currently used to treat drug and alcohol addiction. It may also be effective for the treatment of cocaine dependence. Seventy six percent of subjects completed the trial. The journal publishes novel results of original research which represent an important new lead or significant impact on the field, particularly those addressing genetic and environmental risk factors, neural circuitry and neurochemistry, and important new therapeutic approaches. Overall, baseline abstinence predicted better outcome. In the Dackis et al. Little attention has been directed towards how best to treat these individuals. The mean ASI composite psychiatric score was significantly higher in the modafinil group (.112 vs. .052, Mann Whitney Test Z=-2.1, p=.04), otherwise there were no significant differences between the two groups in any baseline demographic or drug use variable. In the first controlled trial of modafinil, Dackis and colleagues found that modafinil-treated subjects submitted more negative UBT compared to placebo treated subjects (Dackis et al., 2005). Burgeno LM, Farero RD, Murray NL, Panayi MC, Steger JS, Soden ME, Evans SB, Sandberg SG, Willuhn I, Zweifel LS, Phillips PEM. It acts by blocking the "high" feeling produced by drugs and alcohol. Modafinil is approved to treat sleep disorders, but it may also have some benefit in treating depression. In GEE logistic regression models comparing the lowest level of each scale (no craving) to the set of higher levels, the placebo group was significantly more likely to report higher levels than the modafinil group for intensity (OR = 2.04, 95% Ci = (1.06, 3.92), p=0.03) and duration (OR = 1.89, 95% Ci = (1.06, 3.38), p=0.03); there was a similar effect for frequency (OR = 1.51, 95% Ci = (0.84, 2.73)) which was not significant (p=0.11). Express Scripts administers your prescription drug coverage. We anticipate that these subjects will comprise less than 5% of total enrolled subjects. Overall, baseline abstinence predicted better outcome. There was no evidence of a moderator effect for modafinil. This background of potentially promising findings led Schmaal et al. Bethesda, MD 20894, Web Policies The CBT therapy manual and supporting materials were developed for the National Institute on Alcohol Abuse and Alcoholism Project MATCH (Kadden, 1992). Thanks in advance for your time. This line of research adopts a strategy from the attention deficit disorder playbook. Study edits or deletions are displayed in, Meets DSM-IV diagnostic criteria for cocaine and alcohol dependence, as determined by the Structured Clinical Interview (SCID), Has used no less than $200 worth of cocaine in the 30 days prior to study entry, Has used alcohol within 30 days of study entry, as measured by the Timeline Follow Back, Has consumed a minimum of 48 standard alcoholic drinks (average of 12 drinks per week) in a consecutive 30-day period over the 90-day period prior to study entry (i.e., a minimum of 40% days drinking), as measured by the Timeline Follow Back, Has 2 or more days of heavy drinking (defined as 5 or more drinks per day in males and 4 or more drinks per day in females) in a consecutive 30-day period over the 90-day period prior to study entry, as measured by the Timeline Follow Back, Has 5 consecutive days of abstinence from cocaine and alcohol, as determined by self-report and confirmed by a negative urine screen, a negative breathalyzer test, a collateral report, and a score of less than 8 on the Clinical Institute Withdrawal Scale for Alcohol, Lives within commuting distance of the treatment research clinic, Agrees to attend all research visits, including follow-up visits, If female, willing to use a non-oral form of contraception throughout the study, Meets DSM-IV diagnostic criteria for dependence on any substance other than cocaine, alcohol, or nicotine, as determined by the SCID, Has abstained from cocaine or alcohol for 30 consecutive days prior to study entry, Has a positive urine drug screen for any drug other than cocaine in the week prior to study entry (one repeat test is permitted), Meets DSM-IV diagnostic criteria for any of the following current Axis I disorders: panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, or eating disorders, Meets current or lifetime DSM-IV diagnostic criteria for schizophrenia, any psychotic disorder, or organic mental disorder, History of significant blood, lung, endocrine, heart, kidney, or gastrointestinal disease (including a history of heart attack, mitral valve prolapse, left ventricular hypertrophy, or uncontrolled hypertension), Severe medical illness, such as AIDS, active hepatitis, significant hepatocellular injury with either elevated total bilirubin levels greater than 1.3 mg/dl or elevated aspartate aminotransferase (AST) and serum glutamic-pyruvic transaminase (SGPT) levels at least 3.5 times above normal, after the required 3 days of abstinence, History of hypersensitivity to modafinil or naltrexone, Currently using any psychoactive medications, including any anti-seizure medications (with the exception of diphenhydramine if used sparingly for sleep disturbance), Receiving chronic therapy with any drug known to interact adversely with either modafinil or naltrexone, including propranolol, phenytoin, warfarin, or diazepam, Has taken a monoamine oxidase inhibitor within the 30 days prior to study entry, Has taken an investigational drug within the 60 days prior to study entry, Has taken any opiate substitute (methadone, LAAM, buprenorphine) within the 60 days prior to study entry. 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