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A double-blind, placebo-controlled trial of tiagabine for the treatment of cocaine dependence.
Drug Alcohol Depend. 2007 Dec 01; 91(2-3):141-8.DA

Abstract

BACKGROUND

The potential efficacy of tiagabine for treating cocaine dependence is suggested by both pre-clinical research and two small clinical trials.

METHOD

One hundred and forty one participants who met DSM-IV criteria for cocaine dependence were enrolled into this 12-week, double blind, placebo controlled outpatient trial. Participants received either tiagabine (20 mg/day) or matching placebo. All participants received 1h of manualized individual cognitive behavioral therapy on a weekly basis. Outcome measures included cocaine use as determined by self-report confirmed with urine benzoylecgonine (BE) results, and qualitative and quantitative urine toxicology measures. Safety measures included adverse events, EKGs, vital signs, and laboratory tests.

RESULTS

Seventy-nine participants (i.e., 56%) completed the 12-week trial. The safety results suggest that tiagabine was safe and generally well tolerated by the participants. Participants in both groups improved significantly on cocaine craving and global functioning, with no significant differences between the groups. There were no significant changes in cocaine use as measured by self-report confirmed by urine BE or by quantitative urine toxicology results. Qualitative urine toxicology results suggest a possible weak effect for tiagabine in reducing cocaine use.

CONCLUSION

These results suggest that tiagabine, at a dose of 20 mg/day, did not have a robust effect in decreasing cocaine use.

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Authors+Show Affiliations

Winhusen T
Department of Psychiatry, University of Cincinnati College of Medicine, 231 Albert Sabin Way, Cincinnati, OH 45267, USA. winhusen@mdru.uc.edu
Somoza E
No affiliation info available
Ciraulo DA
No affiliation info available
Harrer JM
No affiliation info available
Goldsmith RJ
No affiliation info available
Grabowski J
No affiliation info available
Coleman FS
No affiliation info available
Mindrum G
No affiliation info available
Kahn R
No affiliation info available
Osman S
No affiliation info available
Mezinskis J
No affiliation info available
Li SH
No affiliation info available
Lewis D
No affiliation info available
Horn P
No affiliation info available
Montgomery MA
No affiliation info available
Elkashef A
No affiliation info available

MeSH

AdultAlcoholismCocaine-Related DisordersComorbidityDiagnostic and Statistical Manual of Mental DisordersDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansMaleMiddle AgedNeurotransmitter Uptake InhibitorsNipecotic AcidsPlacebosTiagabineTreatment Outcome

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

17629631

Citation

Winhusen, Theresa, et al. "A Double-blind, Placebo-controlled Trial of Tiagabine for the Treatment of Cocaine Dependence." Drug and Alcohol Dependence, vol. 91, no. 2-3, 2007, pp. 141-8.
Winhusen T, Somoza E, Ciraulo DA, et al. A double-blind, placebo-controlled trial of tiagabine for the treatment of cocaine dependence. Drug Alcohol Depend. 2007;91(2-3):141-8.
Winhusen, T., Somoza, E., Ciraulo, D. A., Harrer, J. M., Goldsmith, R. J., Grabowski, J., Coleman, F. S., Mindrum, G., Kahn, R., Osman, S., Mezinskis, J., Li, S. H., Lewis, D., Horn, P., Montgomery, M. A., & Elkashef, A. (2007). A double-blind, placebo-controlled trial of tiagabine for the treatment of cocaine dependence. Drug and Alcohol Dependence, 91(2-3), 141-8.
Winhusen T, et al. A Double-blind, Placebo-controlled Trial of Tiagabine for the Treatment of Cocaine Dependence. Drug Alcohol Depend. 2007 Dec 1;91(2-3):141-8. PubMed PMID: 17629631.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A double-blind, placebo-controlled trial of tiagabine for the treatment of cocaine dependence. AU - Winhusen,Theresa, AU - Somoza,Eugene, AU - Ciraulo,Domenic A, AU - Harrer,Judy M, AU - Goldsmith,R Jeffrey, AU - Grabowski,John, AU - Coleman,Florence S, AU - Mindrum,Gordon, AU - Kahn,Roberta, AU - Osman,Sabuhi, AU - Mezinskis,Juris, AU - Li,Shou-Hua, AU - Lewis,Daniel, AU - Horn,Paul, AU - Montgomery,Margaret A, AU - Elkashef,Ahmed, Y1 - 2007/07/16/ PY - 2007/03/29/received PY - 2007/05/16/revised PY - 2007/05/17/accepted PY - 2007/7/17/pubmed PY - 2008/4/2/medline PY - 2007/7/17/entrez SP - 141 EP - 8 JF - Drug and alcohol dependence JO - Drug Alcohol Depend VL - 91 IS - 2-3 N2 - BACKGROUND: The potential efficacy of tiagabine for treating cocaine dependence is suggested by both pre-clinical research and two small clinical trials. METHOD: One hundred and forty one participants who met DSM-IV criteria for cocaine dependence were enrolled into this 12-week, double blind, placebo controlled outpatient trial. Participants received either tiagabine (20 mg/day) or matching placebo. All participants received 1h of manualized individual cognitive behavioral therapy on a weekly basis. Outcome measures included cocaine use as determined by self-report confirmed with urine benzoylecgonine (BE) results, and qualitative and quantitative urine toxicology measures. Safety measures included adverse events, EKGs, vital signs, and laboratory tests. RESULTS: Seventy-nine participants (i.e., 56%) completed the 12-week trial. The safety results suggest that tiagabine was safe and generally well tolerated by the participants. Participants in both groups improved significantly on cocaine craving and global functioning, with no significant differences between the groups. There were no significant changes in cocaine use as measured by self-report confirmed by urine BE or by quantitative urine toxicology results. Qualitative urine toxicology results suggest a possible weak effect for tiagabine in reducing cocaine use. CONCLUSION: These results suggest that tiagabine, at a dose of 20 mg/day, did not have a robust effect in decreasing cocaine use. SN - 0376-8716 UR - https://www.unboundmedicine.com/medline/citation/17629631/A_double_blind_placebo_controlled_trial_of_tiagabine_for_the_treatment_of_cocaine_dependence_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0376-8716(07)00238-4 DB - PRIME DP - Unbound Medicine ER -