Modafinil and cocaine: A double-blind, placebo-controlled drug interaction study

Drug and Alcohol Dependence

Volumn 70, Issue 1, 2003, Pages 29-37

  Dackis, Charles A ^a   Lynch, Kevin G ^a   Yu, Elmer ^b   Samaha, Frederick F ^b   Kampman, Kyle M ^a   Cornish, James W ^a,b   Rowan, Amy ^a   Poole, Sabrina ^b   White, Lenae ^a   O'Brien, Charles P ^a,b  

^a UNIVERSITY OF PENNSYLVANIA   (United States)

^b VETERANS AFFAIRS MEDICAL CENTER   (United States)

Author keywords

Cocaine; Drug interaction; Euphoria; Modafinil; Safety

Indexed keywords

COCAINE; MODAFINIL; PLACEBO;

ADULT; ARTICLE; BLOOD PRESSURE; BODY TEMPERATURE; CLINICAL ARTICLE; CLINICAL TRIAL; COCAINE DEPENDENCE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFECT; DRUG MEGADOSE; DRUG SAFETY; ELECTROCARDIOGRAM; EUPHORIA; HUMAN; LOW DRUG DOSE; MALE; OPEN STUDY; PRIORITY JOURNAL; PULSE RATE; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; WITHDRAWAL SYNDROME;

ADULT; BENZHYDRYL COMPOUNDS; BLOOD PRESSURE; BODY TEMPERATURE; CENTRAL NERVOUS SYSTEM STIMULANTS; COCAINE; COCAINE-RELATED DISORDERS; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG INTERACTIONS; HUMANS; MALE; MIDDLE AGED; PULSE;

EUPHORIA;

EID: 0037401522     PISSN: 03768716     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0376-8716(02)00335-6     Document Type: Article

References (81)

1. Akaoka H., Roussel B., Lin J.S., Chouvet G., Jouvet M. Effect of modafinil and amphetamine on the rat catecholaminergic neuron activity. Neurosci. Lett. 123:1991;20-22.
2. Alterman A.I., McKay J.R., Mulvaney F.D., McLellan A.T. Prediction of attrition from day hospital treatment in lower socioeconomic cocaine-dependent men. Drug Alcohol Depend. 40:1996;227-233.
3. Alterman A.I., O'Brien C.P., McLellan A.T., August D.S., Snider E.C., Droba M., Cornish J.W., Hall C.P., Raphaelson A.H., Schrade F.X. Effectiveness and costs of inpatient versus day hospital cocaine rehabilitation. J. Nerv. Ment. Dis. 182:1994;157-163.
4. Alterman A.I., Snider E.C., Cacciola J.S., May D.J., Parikh G., Maany I., Rosenbaum P.R. A quasi-experimental comparison of the effectiveness of 6-versus 12-hour per week outpatient treatments for cocaine dependence. J. Nerv. Ment. Dis. 184:1996;54-56.
5. Besset A., Chetrit M., Carlander B., Billiard M. Use of modafinil in the treatment of narcolepsy: a long term follow-up study. Neurophysiol. Clin. 26:1996;60-66.
6. Beusterien K.M., Rogers A.E., Walsleben J.A., Emsellem H.A., Reblando J.A., Wang L., Goswami M., Steinwald B. Health-related quality of life effects of modafinil for treatment of narcolepsy. Sleep. 22:1999;757-765.
7. Bourdon L., Jacobs I., Bateman W.A., Vallerand A.L. Effect of modafinil on heat production and regulation of body temperatures in cold-exposed humans. Aviat. Space Environ. Med. 65:1994;999-1004.
8. Brun J., Chamba G., Khalfallah Y., Girard P., Boissy I., Bastuji H., Sassolas G., Claustrat B. Effect of modafinil on plasma melatonin, cortisol and growth hormone rhythms, rectal temperature and performance in healthy subjects during a 36 h sleep deprivation. J. Sleep Res. 7:1998;105-114.
9. Carroll K.M., Rounsaville B.J., Gawin F.H. A comparative trial of psychotherapies for ambulatory cocaine abusers: relapse prevention and interpersonal psychotherapy. Am. J. Drug Alcohol Abuse. 17:1991;229-247.
10. Carroll K.M., Rounsaville B.J., Gordon L.T., Nich C., Jatlow P., Bisighini R.M., Gawin F.H. Psychotherapy and pharmacotherapy for ambulatory cocaine abusers. Arch. Gen. Psychiatry. 51:1994;177-187.
11. Cascella N., Muntaner C., Kumor K.M., Nagoshi C.T., Jaffe J.H., Sherer M.A. Cardiovascular responses to cocaine placebo in humans: a preliminary report. Biol. Psychiatry. 25:1989;285-295.
12. Chakko S., Myerburg R.J. Cardiac complications of cocaine abuse. Clin. Cardiol. 18:1995;67-72.
13. Coffey S.F., Dansky B.S., Carrigan M.H., Brady K.T. Acute and protracted cocaine abstinence in an outpatient population: a prospective study of mood, sleep and withdrawal symptoms. Drug Alcohol Depend. 59:2000;277-286.
14. Combs A.B., Acosta D. Toxic mechanisms of the heart: a review. Toxicol. Pathol. 18:1990;583-596.
15. Cottler L.B., Shillington A.M., Compton W.M., Mager D., Spitznagal E.L. Subjective reports of withdrawal among cocaine users: recommendations for DSM-IV. Drug Alcohol Depend. 33:1993;97-104.
16. Dackis C.A., Gold M.S. New concepts in cocaine addiction: the dopamine depletion hypothesis. Neurosci. Biobehav. Rev. 9:1985;469-477.
17. Dackis C.A., O'Brien C.P. Cocaine dependence: a disease of the brain's reward centers. J. Subst. Abuse Treat. 21:2001;111-117.
18. Dackis C.A., O'Brien C.P. Cocaine dependence: the challenge for pharmacotherapy. Curr. Opin. Psychiatry. 15:2002;261-268.
19. Dackis C.A., O'Brien C.P. The neurobiology of addiction. Asbury A., Goadsby P.J., McArthur J. Diseases of the Nervous System. third ed. 2002;431-444 Cambridge University Press, Cambridge.
20. Daras M., Tuchman A.J., Marks S. Central nervous system infarction related to cocaine abuse. Stroke. 22:1991;1320-1325.
21. Duteil J., Rambert F.A., Pessonnier J., Hermant J.F., Gombert R., Assous E. Central alpha 1-adrenergic stimulation in relation to the behaviour stimulating effect of modafinil; studies with experimental animals. Eur. J. Pharmacol. 180:1990;49-58.
22. Ferraro L., Antonelli T., O'Connor W.T., Tanganelli S., Rambert F.A., Fuxe K. Modafinil: an antinarcoleptic drug with a different neurochemical profile to d-amphetamine and dopamine uptake blockers. Biol. Psychiatry. 42:1997;1181-1183.
23. Ferraro L., Antonelli T., O'Connor W.T., Tanganelli S., Rambert F.A., Fuxe K. The effects of modafinil on striatal, pallidal and nigral GABA and glutamate release in the conscious rat: evidence for a preferential inhibition of striato-pallidal GABA transmission. Neurosci. Lett. 253:1998;135-138.
24. Ferraro L., Tanganelli S., O'Connor W.T., Antonelli T., Rambert F., Fuxe K. The vigilance promoting drug modafinil decreases GABA release in the medial preoptic area and in the posterior hypothalamus of the awake rat: possible involvement of the serotonergic 5-HT3 receptor. Neurosci. Lett. 220:1996;5-8.
25. Gamouras G.A., Monir G., Plunkitt K., Gursoy S., Dreifus L.S. Cocaine abuse: repolarization abnormalities and ventricular arrhythmias. Am. J. Med. Sci. 320:2000;9-12.
26. Gawin F.H., Kleber H.D. Abstinence symptomatology and psychiatric diagnosis in cocaine abusers. Clinical observations. Arch. Gen. Psychiatry. 43:1986;107-113.
27. Gold L.H., Balster R.L. Evaluation of the cocaine-like discriminative stimulus effects and reinforcing effects of modafinil. Psychopharmacology. 126:1996;286-292.
28. Haertzen C.A. Addiction Research Center Inventory (ARCI): development of a general drug estimation scale. J. Nerv. Ment. Dis. 141:1965;300-307.
29. Higgins S.T., Budney A.J., Bickel W.K., Hughes J.R., Foerg F., Badger G. Achieving cocaine abstinence with a behavioral approach. Am. J. Psychiatry. 150:1993;763-769.
30. Ikemoto S., Kohl R.R., McBride W.J. GABA(A) receptor blockade in the anterior ventral tegmental area increases extracellular levels of dopamine in the nucleus accumbens of rats. J. Neurochem. 69:1997;137-143.
31. Imperato A., Mele A., Scrocco M.G., Puglisi-Allegra S. Chronic cocaine alters limbic extracellular dopamine. Neurochemical basis for addiction. Eur. J. Pharmacol. 212:1992;299-300.
32. Jacobs I.G., Roszler M.H., Kelly J.K., Klein M.A., Kling G.A. Cocaine abuse: neurovascular complications. Radiology. 170:1989;223-227.
33. Jaffe J.H., Cascella N.G., Kumor K.M., Sherer M.A. Cocaine-induced cocaine craving. Psychopharmacology. 97:1989;59-64.
34. Jasinski D.R. An evaluation of the abuse potential of modafinil using methylphenidate as a reference. J. Psychopharmacol. 14:2000;53-60.
35. Jasinski D.R., Kovacevic-Ristanovic R. Evaluation of the abuse liability of modafinil and other drugs for excessive daytime sleepiness associated with narcolepsy. Clin. Neuropharmacol. 23:2000;149-156.
36. Kalivas P.W., Duffy P. Repeated cocaine administration alters extracellular glutamate in the ventral tegmental area. J. Neurochem. 70:1998;1497-1502.
37. Kampman K.M., Alterman A.I., Volpicelli J.R., Maany I., Muller E.S., Luce D.D., Mulholland E.M., Jawad A.F., Parikh G.A., Mulvaney F.D., Weinrieb R.M., O'Brien C.P. Cocaine withdrawal symptoms and initial urine toxicology results predict treatment attrition in outpatient cocaine dependence treatment. Psychol. Addict. Behav. 15:2001;52-59.
38. Kampman K.M., Volpicelli J.R., McGinnis D.E., Alterman A.I., Weinrieb R.M., D'Angelo L., Epperson L.E. Reliability and validity of the cocaine selective severity assessment. Addict. Behav. 23:1998;449-461.
39. Kang S.Y., Kleinman P.H., Woody G.E., Millman R.B., Todd T.C., Kemp J., Lipton D.S. Outcomes for cocaine abusers after once-a-week psychosocial therapy. Am. J. Psychiatry. 148:1991;630-635.
40. Karreman M., Moghaddam B. The prefrontal cortex regulates the basal release of dopamine in the limbic striatum: an effect mediated by ventral tegmental area. J. Neurochem. 66:1996;589-598.
41. Kaufman M.J., Levin J.M., Kukes T.J., Villafuerte R.A., Hennen J., Lukas S.E., Mendelson J.H., Renshaw P.F. Illicit cocaine use patterns in intravenous-naïve cocaine users following investigational intravenous cocaine administration. Drug Alcohol Depend. 58:2000;35-42.
42. Kerns W. II, Garvey L., Owens J. Cocaine-induced wide complex dysrhythmia. J. Emerg. Med. 15:1997;321-329.
43. Keys A.S., Mark G.P., Emre N., Meshul C.K. Reduced glutamate immunolabeling in the nucleus accumbens following extended withdrawal from self-administered cocaine. Synapse. 30:1998;393-401.
44. Kokkinos J., Levine S.R. Stroke. Neurol. Clin. 11:1993;577-590.
45. Koob G.F., Sanna P.P., Bloom F.E. Neuroscience of addiction. Neuron. 21:1998;467-476.
46. Lange R.A., Hillis L.D. Cardiovascular complications of cocaine use. N. Engl. J. Med. 345:2001;351-358.
47. Lin J.S., Hou Y., Jouvet M. Potential brain neuronal targets for amphetamine-, methylphenidate-, and modafinil-induced wakefulness, evidenced by c-fos immunocytochemistry in the cat. Proc. Natl. Acad. Sci. USA. 93:1996;14128-14133.
48. Lin J.S., Roussel B., Akaoka H., Fort P., Debilly G., Jouvet M. Role of catecholamines in the modafinil and amphetamine induced wakefulness, a comparative pharmacological study in the cat. Brain Res. 591:1992;319-326.
49. Littell R.C., Milliken G.A., Stroup W.W., Wolfinger R.D. SAS System for Mixed Models. 1996;SAS Institute Inc, Cary, NC.
50. Little K.Y., Zhang L., Desmond T., Frey K.A., Dalack G.W., Cassin B.J. Striatal dopaminergic abnormalities in human cocaine users. Am. J. Psychiatry. 156:1999;238-245.
51. Loghmanee F., Tobak M. Fatal malignant hyperthermia associated with recreational cocaine and ethanol abuse. Am. J. Forensic Med. Pathol. 7:1986;246-248.
52. Lyons T.J., French J. Modafinil: the unique properties of a new stimulant. Aviat. Space Environ. Med. 62:1991;432-435.
53. Malcolm R.J., Donovan J.L., DeVane C.L., Elkashef A., Chiang N., Mojsiak J. Influence of modafinil, 400 or 800 mg/day on subjective effects of intravenous cocaine in non-treatment-seeking volunteers. Drug Alcohol Depend. 66:2002;S110.
54. Markou A., Koob G.F. Postcocaine anhedonia. An animal model of cocaine withdrawal. Neuropsychopharmacology. 4:1991;17-26.
55. Menza M.A., Kaufman K.R., Castellanos A. Modafinil augmentation of antidepressant treatment in depression. J. Clin. Psychiatry. 61:2000;378-381.
56. Mignot E., Nishino S., Guilleminault C., Dement W.C. Modafinil binds to the dopamine uptake carrier site with low affinity. Sleep. 17:1994;436-437.
57. Mitchell P.B. Novel French antidepressants not available in the United States. Psychopharmacol. Bull. 31:1995;509-519.
58. Mulvaney F.D., Alterman A.I., Boardman C.R., Kampman K. Cocaine abstinence symptomatology and treatment attrition. J. Subst. Abuse Treat. 16:1999;129-135.
59. Nicolaidis S., De Saint Hilaire Z. Nonamphetamine awakening agent modafinil induces feeding changes in the rat. Brain Res. Bull. 32:1993;87-90.
60. Nolte K.B., Brass L.M., Fletterick C.F. Intracranial hemorrhage associated with cocaine abuse: a prospective autopsy study. Neurology. 46:1996;1291-1296.
61. O'Brien C.P., Childress A.R., McLellan A.T., Ehrman R. Classical conditioning in drug-dependent humans. Ann. N.Y. Acad. Sci. 654:1992;400-415.
62. Parsons L.H., Smith A.D., Justice J.B. Jr. Basal extracellular dopamine is decreased in the rat nucleus accumbens during abstinence from chronic cocaine. Synapse. 9:1991;60-65.
63. Perez de la Mora M., Aguilar-Garcia A., Ramon-Frias T., Ramirez-Ramirez R., Mendez-Franco J., Rambert F., Fuxe K. Effects of the vigilance promoting drug modafinil on the synthesis of GABA and glutamate in slices of rat hypothalamus. Neurosci. Lett. 259:1999;181-185.
64. Pierard C., Satabin P., Lagarde D., Barrere B., Guezennec C.Y., Menu J.P., Peres M. Effects of a vigilance-enhancing drug, modafinil, on rat brain metabolism: a 2D COSY 1H-NMR study. Brain Res. 693:1995;251-256.
65. Pigeau R., Naitoh P., Buguet A., McCann C., Baranski J., Taylor M., Thompson M., Mac K.I.I. Modafinil, D-amphetamine and placebo during 64 hours of sustained mental work. I. Effects on mood, fatigue, cognitive performance and body temperature. J. Sleep Res. 4:1995;212-228.
66. Reid M.S., Hsu K. Jr., Berger S.P. Cocaine and amphetamine preferentially stimulate glutamate release in the limbic system: studies on the involvement of dopamine. Synapse. 27:1997;95-105.
67. Robertson M.W., Leslie C.A., Bennett J.P. Jr. Apparent synaptic dopamine deficiency induced by withdrawal from chronic cocaine treatment. Brain Res. 538:1991;337-339.
68. Rugino T.A., Copley T.C. Effects of modafinil in children with attention-deficit/hyperactivity disorder: an open-label study. J. Am. Acad. Child Adolescence Psychiatry. 40:2001;230-235.
69. Saletu B., Frey R., Krupka M., Anderer P., Grunberger J., Barbanoj M.J. Differential effects of the new central adrenergic agonist modafinil and D-amphetamine on sleep and early morning behaviour in elderlies. Arzneimittelforschung. 39:1989;1268-1273.
70. Satel S.L., Price L.H., Palumbo J.M., McDougle C.J., Krystal J.H., Gawin F., Charney D.S., Heninger G.R., Kleber H.D. Clinical phenomenology and neurobiology of cocaine abstinence: a prospective inpatient study (see comments). Am. J. Psychiatry. 148:1991;1712-1716.
71. Schultz W. Reward signaling by dopamine neurons. Neuroscientist. 7:2001;293-302.
72. Simon P., Hemet C., Ramassamy C., Costentin J. Non-amphetaminic mechanism of stimulant locomotor effect of modafinil in mice. Eur. Neuropsychopharmacol. 5:1995;509-514.
73. Tanganelli S., Perez de la Mora M., Ferraro L., Mendez-Franco J., Beani L., Rambert F.A., Fuxe K. Modafinil and cortical gamma-aminobutyric acid outflow. Modulation by 5-hydroxytryptamine neurotoxins. Eur. J. Pharmacol. 273:1995;63-71.
74. Volkow N.D., Wang G.J., Fowler J.S., Logan J., Gatley S.J., Hitzemann R., Chen A.D., Dewey S.L., Pappas N. Decreased striatal dopaminergic responsiveness in detoxified cocaine-dependent subjects. Nature. 386:1997;830-833.
75. Weddington W.W., Brown B.S., Haertzen C.A., Cone E.J., Dax E.M., Herning R.I., Michaelson B.S. Changes in mood, craving, and sleep during short-term abstinence reported by male cocaine addicts. A controlled, residential study. Arch. Gen. Psychiatry. 47:1990;861-868.
76. Wetli C.V., Fishbain D.A. Cocaine-induced psychosis and sudden death in recreational cocaine users. J. Forensic Sci. 30:1985;873-880.
77. Wise R.A. Neurobiology of addiction. Curr. Opin. Neurobiol. 6:1996;243-251.
78. Wong Y.N., King S.P., Laughton W.B., McCormick G.C., Grebow P.E. Single-dose pharmacokinetics of modafinil and methylphenidate given alone or in combination in healthy male volunteers. J. Clin. Pharmacol. 38:1998;276-282.
79. Wong Y.N., Simcoe D., Hartman L.N., Laughton W.B., King S.P., McCormick G.C., Grebow P.E. A double-blind, placebo-controlled, ascending-dose evaluation of the pharmacokinetics and tolerability of modafinil tablets in healthy male volunteers. J. Clin. Pharmacol. 39:1999;30-40.
80. Wong Y.N., Wang L., Hartman L., Simcoe D., Chen Y., Laughton W., Eldon R., Markland C., Grebow P. Comparison of the single-dose pharmacokinetics and tolerability of modafinil and dextroamphetamine administered alone or in combination in healthy male volunteers. J. Clin. Pharmacol. 38:1998;971-978.
81. Wu J.C., Bell K., Najafi A., Widmark C., Keator D., Tang C., Klein E., Bunney B.G., Fallon J., Bunney W.E. Decreasing striatal 6-FDOPA uptake with increasing duration of cocaine withdrawal. Neuropsychopharmacology. 17:1997;402-409.