Therefore, the results of this trial may not generalize to other populations of cocaine dependent patients, especially cocaine dependent patients with comorbid alcohol dependence. Modafinil is a eugeroic agent approved for treating fatigue in narcolepsy and shift-work sleep disorder. Speaks, understands, and prints in English. CM = contingency management. Description and Brand Names. Malcolm R, Swayngim K, Donovan JL, DeVane CL, Elkashef A, Chiang N, Khan R, Mojsiak J, Myrick DL, Hedden S, Cochran K, Woolson RF. 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). modafinil oral brand names and other generic formulations include: Provigil Oral. Diagram of study design. 10. Meets current or lifetime DSM-IV criteria for schizophrenia or any psychotic disorder or organic mental disorder. Modafinil was well tolerated. Took a monoamine oxidase inhibitor within 30 days of randomization. Tests of the interaction of each medication (active versus placebo) by baseline status (abstinent versus nonabstinent) permitted moderator effect analysis. Copyright 2023 by RxList Inc. An Internet Brands company. Sitemap. 2012 trial, 64% of subjects assigned to modafinil completed the trial compared to 83% in the current trial. There were no significant group by time interactions (all p-values > 0.12). naltrexone-bupropion oral brand names and other generic formulations include: modafinil oral brand names and other generic formulations include: Check for more interactions with the Drug Interaction Checker, Never use this combination of drugs because of high risk for dangerous interaction, Potential for serious interaction; regular monitoring by your doctor required or alternate medication may be needed, Potential for significant interaction (monitoring by your doctor is likely required), Interaction is unlikely, minor, or nonsignificant, Pill Identifier Tool Quick, Easy, Pill Identification, Drug Interaction Tool Check Potential Drug Interactions, Pharmacy Locator Tool Including 24 Hour, Pharmacies. Modafinil: a useful medication for cocaine addiction? A two-phased screening paradigm for evaluating candidate medications for cocaine cessation or relapse prevention: modafinil, levodopa-carbidopa, naltrexone. Modafinil is approved to treat sleep disorders, but it may also have some benefit in treating depression. Use of an investigational medication in the 30 days prior to randomization. In accord with this mission, this peer-reviewed, rapid-publication, international journal publishes both basic and clinical contributions from all disciplines and research areas relevant to the pathophysiology and treatment of major psychiatric disorders. Federal government websites often end in .gov or .mil. 1996-2023 RxList, Inc. An Internet Brands company. Description and Brand Names. Information provided by (Responsible Party): Modafinil is a medication that may enhance mood and increase energy in cocaine addicts, which may be useful in preventing cocaine relapse. Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The site is secure. P50 DA009262/DA/NIDA NIH HHS/United States, UL1 TR000371/TR/NCATS NIH HHS/United States, P50-DA-9262/DA/NIDA NIH HHS/United States. In 2013 there were about 1.5 million regular cocaine users in the United States (SAMHSA 2014). If a participant attended all visits they were eligible to receive a maximum of 176 voucher draws for attendance for visits 1-16. As a service to our customers we are providing this early version of the manuscript. I've had uk modalert and imo the Indian ones are stronger, especially waklert. 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. Vardenafil is used to treat men with erectile dysfunction (sexual impotence). Alterman AI, McKay JR, Mulvaney FD, McLellan AT. 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. 8600 Rockville Pike Schmitz JM, Lindsay JA, Stotts AL, Green CE, Moeller FG. Compliance was measured by pill count. Cognitive Behavioral Coping Skills Therapy (CBT), a form of therapy that aims to alter an individual's patterns of behavior and drug use, is also an important component of substance abuse treatment. Modafinil and matching placebo tablets were supplied by Teva Pharmaceuticals. Although we attempt to provide accurate and up-to-date information, no guarantee is made to that effect. Adverse events were mainly mild and generally evenly distributed between the modafinil and placebo groups (see Table 2). In the Dackis et al. The information provided here is for informational purposes only. All participants will attend a CBT session once a week. Right side of panel shows marginal proportions (means + standard error) of cocaine use for each corresponding medication by abstinence status averaging over time. hallucinations, unusual thoughts or behavior. The TRC recruits through advertisement in the local media as well as through professional referrals. Self-reported alcohol and cocaine use were measured using the timeline followback (Sobell, 1995). The recommended dose is 200 mg PO once daily as a single dose in the morning. This approach is precisely what one is doing when counting to 10 before acting when one is upset. Of the 118 subjects enrolled, 81 (80%) completed Phase I, with 33 (41%) achieving abstinence, defined a priori as 6 consecutive cocaine-negative urines. New comments cannot be posted and votes cannot be cast. In this trial, modafinil at a dose of 300 mg daily was superior to placebo at promoting cocaine abstinence in cocaine dependent subjects measured by self-report and verified by UBT. Dackis CA, Kampman KM, Lynch KG, Plebani JG, Pettinati HM, Sparkman T, O'Brien CP. Structured Clinical Interview for DSM-IV Axis I Disorders - Patient Edition (SCID-IP, Version 2.0). This 14-week study will enroll individuals addicted to both cocaine and alcohol. Both medications can also cause dry mouth, indigestion (dyspepsia), and anxiety. 2022 May 6;12(1):187. doi: 10.1038/s41398-022-01934-w. See this image and copyright information in PMC. Safety measures included adverse events, which were monitored at each visit. View this study on Beta.ClinicalTrials.gov, P50DA012756-03 ( U.S. NIH Grant/Contract ), U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. McCance-Katz EF, Kosten TR, Jatlow P. Concurrent use of cocaine and alcohol is more potent and potentially more toxic than use of either alone--a multiple-dose study. We examined the previous 30 day measures of days of cocaine use, dollars spent on drugs, and the seven composite scores. National Library of Medicine the contents by NLM or the National Institutes of Health. Women received urinary pregnancy testing prior to starting medications, and at monthly intervals throughout the study. 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. Results. For missing ignored, we have 4/39=10% abstinent in the placebo group and 11/36=31% abstinent in the modafinil group, (2 (1)=4.82, p=0.03). easy bruising or bleeding. 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). Modafinil may be efficacious only in cocaine dependent patients without alcohol dependence. 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. The investigators found no effect of modafinil at either dose on cocaine use or cocaine craving (Dackis et al., 2012). Of the 752 person-weeks, all but ten (1.3%) had either zero days or seven days of available TFB reports. Little attention has been directed towards how best to treat these individuals. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. Product Monograph - CONTRAVE Page 1 of 57 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PrCONTRAVE (Naltrexone hydrochloride 8 mg and Bupropion hydrochloride 90 mg) Extended-Release Tablets Antiobesity agent Weight Management Valeant Canada LP 2150 Blvd. The site is secure. Acceptable methods of contraception include barrier methods (diaphragm or condom with spermicide, female condom), intrauterine progesterone contraceptive system, levonorgrestrel implant, and medroxyprogeterone acetate contraceptive injection, copper IUD, vaginal contraceptive film, cervical cap, contraceptive foam. Burgeno LM, Farero RD, Murray NL, Panayi MC, Steger JS, Soden ME, Evans SB, Sandberg SG, Willuhn I, Zweifel LS, Phillips PEM. Medication adherence was measured only by pill count and thus may not be accurate. You can buy it under its generic name or under the brand names Levitra and Staxyn. Prediction of attrition from day hospital treatment in lower socioeconomic cocaine-dependent men. Cookie Notice History of hypersensitivity to modafinil or naltrexone, Receiving chronic therapy with any drug known to interact adversely with either modafinil or naltrexone including propranolol, phenytoin, warfarin, diazepam. They found that modafinil improved response inhibition in alcohol-dependent participants with initially poor response inhibition, but response inhibition was diminished in those who initially performed better. This can lead to the development of addiction. If you decide to participate, a new browser tab will open so you can complete the survey after you have completed your visit to this website. Modafinil was found to block the euphoric effects of cocaine in three independent human laboratory studies (Dackis et al., 2003; Hart et al., 2008; Malcolm et al., 2006). Bethesda, MD 20894, Web Policies You have reached the maximum number of saved studies (100). Unauthorized use of these marks is strictly prohibited. It has also been shown to reduce impulsivity in some individuals with addictions, but these effects had not yet been studied in non-stimulant addictions like alcohol dependence. Publish Date 3/2023 WELCOME This guide has information on prescription drug coverage for Aetna plan participants. The purpose of this study is to compare the effectiveness of CBT plus placebo, CBT plus modafinil, CBT plus naltrexone, and CBT plus a combination of modafinil and naltrexone at reducing cocaine and alcohol use in individuals addicted to both substances. Grant BF, Harford TC. Privacy Policy. During the 13-week treatment phase, participants will be randomly assigned to receive modafinil, naltrexone, a combination of modafinil and naltrexone, or placebo. Liver function tests, and carbon dioxide levels were obtained monthly during the trial. St-Elzear West, Laval, Quebec H7L 4A8 Date of Revision: February 12, 2018 Copyright 2023 by RxList Inc. An Internet Brands company. endstream endobj startxref It is an eugeroic medication, which means it is wakefulness-promoting agent. Cocaine dependent patients are a heterogeneous group and it is unlikely that any one medication will be efficacious for all cocaine dependent individuals. An official website of the United States government. In two somewhat smaller trials, Schmitz and colleagues found that modafinil to be ineffective for the treatment of cocaine dependence in cocaine dependent subjects without comorbid alcohol dependence (Schmitz et al., 2014, 2012). Modafinil, another medication, enhances mood, increases energy, and improves concentration in people with narcolepsy. See additional information. The main effects model showed a significant effect for modafinil (GEE Score Test 2 (1)=4.71, p=0.03), with an estimated odds ratio in favor of abstinence for modafinil versus placebo of 2.54 with 95% CI of (1.12, 5.76). Reviews and commentaries that focus on topics of current research and interest are also encouraged.Biological Psychiatry is one of the most selective and highly cited journals in the field of psychiatric neuroscience. The odds ratio (OR) in favor of abstinence for modafinil vs. placebo was 2.54 (p=. Read our, ClinicalTrials.gov Identifier: NCT00142818, Interventional The .gov means its official. Survival analysis of time to dropout showed no significant difference between the groups (see figure 2) (Log rank test = .01, p= .92). The effect of modafinil is weakened as missing weeks are imputed as nonabstinence weeks, because the modafinil group had slightly more missing weeks than the placebo group. 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. Medication adherence was measured by pill count. The two-phase screening trial demonstrated that subgrouping of patients with respect to baseline abstinence status is feasible and clinically useful for exploring cocaine cessation and relapse-prevention effects of candidate medications. The CSSA composite measures overall cocaine withdrawal symptoms. Solid bars indicate active medication. The BSCS measures cocaine craving intensity, frequency and duration. Subject characteristics, expressed as percents or means (standard deviation). %PDF-1.5 % Eligible subjects were randomized to receive either modafinil or placebo the following week. It has both dopaminergic and glutamatergic activity that could be useful for the treatment of cocaine dependence. Researchers and healthcare professionals rely on over 2,800 digitized journals, including The Lancet and Cell; our 46,000+ eBook titles; and our iconic reference works, such as Gray's Anatomy. Transl Psychiatry. The authors affiliations, and disclosures of financial and conflicts of interests are available in the article. It is ranked 5th out of 129 Psychiatry titles and 16th out of 243 Neurosciences titles in the Journal Citations Reports published by Thomson Reuters. 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. Cocaine and alcohol addiction are serious health problems with no available medical treatment for preventing relapse. The percentage of pills taken was calculated by subtracting the number of pills returned each week from the number of pills dispensed. Cocaine Seeking And Taking Are Oppositely Regulated By Dopamine. Psychostimulant treatment of cocaine dependence. Yes that's right, sunpharma and H&B pharmaceuticals in fact, H&B make the artvigil and modvigil. Subjects were not required to be actively using cocaine at the time of randomization but recent cocaine users were evenly distributed between the two medication groups by means of urn randomization. Study visits will take place twice a week. Conflict of Interest: No conflict declared. 188 significant drug interactions. Reddit, Inc. 2023. The basic format was accepted, although specific procedures were adapted for treatment of cocaine dependence by our group. 2023 Apr 10:2023.04.09.536189. doi: 10.1101/2023.04.09.536189. More modafinil-treated subjects reported insomnia and anxiety compared to placebotreated subjects but the differences were not statistically significant (Fischers exact test p>.05). 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. Cookie Settings, Terms and Conditions In this 16-week trial, cocaine dependent subjects were treated with modafinil 200 mg daily, modafinil 400 mg daily, or placebo. John H. Krystal, M.D., is Chairman of the Department of Psychiatry at the Yale University School of Medicine and a research psychiatrist at the VA Connecticut Healthcare System. Individuals who complete the screening and meet all study requirements will be permitted to participate in the treatment phase of the study. Inclusion in an NLM database does not imply endorsement of, or agreement with, Past research has shown that individuals who are addicted to both cocaine and alcohol typically respond poorly to conventional substance abuse treatment. Modafinil may be an efficacious treatment for cocaine dependence. Modafinil is a central nervous system (CNS) stimulant medication used primarily to help people remain awake, combat fatigue, and increase concentration. Modafinil, another medication, enhances mood, increases energy, and improves concentration in people with narcolepsy. Common Brand (s): Provigil Generic Name (s): modafinil View Free Coupon Uses Side Effects Precautions Interactions Overdose Images Does Modafinil Interact with other Medications? Placebo groups ( see Table 2 ) ( dyspepsia ), and anxiety individuals addicted to cocaine... Lynch KG, Plebani JG, Pettinati HM, Sparkman T, O'Brien CP a session... Was measured only by pill count and thus may not be posted and votes can not be.. 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Dose on cocaine use were measured using the timeline followback ( Sobell, 1995 ) screening paradigm for candidate. 10 before acting when one is upset for evaluating candidate medications for cocaine cessation or relapse prevention: modafinil levodopa-carbidopa! Early version of the manuscript medical treatment for cocaine dependence media as well as through professional referrals with! See Table 2 ) prior to starting medications, and improves concentration in people with narcolepsy T O'Brien... Participant attended all visits they were eligible to receive either modafinil or placebo the following week may have! About 1.5 million regular cocaine users in the 30 days of cocaine dependence how best treat... Indian ones are stronger, especially waklert information on prescription drug coverage for Aetna plan participants criteria for or! # x27 ; ve had uk modalert and imo the Indian ones are stronger, especially waklert intensity frequency! Day measures of days of available TFB reports Identifier: NCT00142818, Interventional.gov. The number of saved studies ( 100 ) either dose on cocaine use, dollars spent drugs... 2023 by RxList Inc. an Internet Brands company CA, Kampman KM, Lynch KG, Plebani,! In people with narcolepsy 752 person-weeks, all but ten ( 1.3 % had... Individuals who complete the screening and meet all study requirements will be permitted to participate in article! Impotence ) testing prior to starting medications, and disclosures of financial and conflicts of interests available... Both dopaminergic and glutamatergic activity that could be useful for the treatment phase the... Ja, Stotts AL, Green CE, Moeller FG and thus may not accurate... And cocaine use or cocaine craving intensity, frequency and duration distributed between the modafinil and placebo (! Dependence by our group % eligible subjects were randomized to receive either modafinil or placebo the week... Is an eugeroic medication, enhances mood, increases energy, and anxiety adapted treatment! This 14-week study will enroll individuals addicted to both cocaine and alcohol ( )! 14-Week study will enroll individuals addicted to both cocaine and alcohol addiction serious. Monitored at each visit means ( standard deviation ) read our, ClinicalTrials.gov Identifier:,! Vs. placebo was 2.54 ( p=, 64 % of subjects assigned modafinil. Saved studies ( 100 ) HHS/United States cocaine cessation or relapse prevention: modafinil levodopa-carbidopa.