A double-blind, placebo-controlled trial of tiagabine for the treatment of cocaine dependence

Theresa Winhusen; Eugene Somoza; Domenic A. Ciraulo; Judy M. Harrer; R. Jeffrey Goldsmith; John Grabowski; Florence S. Coleman; Gordon Mindrum; Roberta Kahn; Sabuhi Osman; Juris Mezinskis; Shou Hua Li; Daniel Lewis; Paul Horn; Margaret A. Montgomery; Ahmed Elkashef

doi:10.1016/j.drugalcdep.2007.05.028

A double-blind, placebo-controlled trial of tiagabine for the treatment of cocaine dependence

Theresa Winhusen, Eugene Somoza, Domenic A. Ciraulo, Judy M. Harrer, R. Jeffrey Goldsmith, John Grabowski, Florence S. Coleman, Gordon Mindrum, Roberta Kahn, Sabuhi Osman, Juris Mezinskis, Shou Hua Li, Daniel Lewis, Paul Horn, Margaret A. Montgomery, Ahmed Elkashef

Research output: Contribution to journal › Article › peer-review

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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 1 h 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.

Original language	English (US)
Pages (from-to)	141-148
Number of pages	8
Journal	Drug and alcohol dependence
Volume	91
Issue number	2-3
DOIs	https://doi.org/10.1016/j.drugalcdep.2007.05.028
State	Published - Dec 1 2007
Externally published	Yes

Bibliographical note

Funding Information:
This study was supported by the National Institutes of Health, National Institute on Drug Abuse through contract N01-DA-9-8095 (E. Somoza). The study medication and matching placebo were provided by Cephalon at no cost. Dr. Ciraulo has served as a consultant for Alkermes, Astra Zeneca, Bristol Myers Squibb, Cephalon, Johnson & Johnson, Ortho-McNeil, and UCB Pharma. We thank the faculty and staff at the study sites for their contributions to this project. In particular we wish to thank Jacqueline Carter, B.S., Cindy Schulze, B.A., Rachel Heffield, B.A., Daniel Owens, L.S.W., Ron Coleman, B.A., Eva Moore, Julie Jansen, B.A., Cathy Otto, M.A., Barbara Thomas, M.A., Daniel Alfaro, M.D. We thank Gerardo González, M.D. for his assistance in reproducing his primary analysis with our study data.

Keywords

Clinical trial
Cocaine dependence
Double-blind
Tiagabine

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Publisher link

10.1016/j.drugalcdep.2007.05.028

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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), 141-148. https://doi.org/10.1016/j.drugalcdep.2007.05.028

Winhusen, T, Somoza, E, Ciraulo, DA, Harrer, JM, Goldsmith, RJ, Grabowski, J, Coleman, FS, Mindrum, G, Kahn, R, Osman, S, Mezinskis, J, Li, SH, Lewis, D, Horn, P, Montgomery, MA & Elkashef, A 2007, 'A double-blind, placebo-controlled trial of tiagabine for the treatment of cocaine dependence', Drug and alcohol dependence, vol. 91, no. 2-3, pp. 141-148. https://doi.org/10.1016/j.drugalcdep.2007.05.028

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title = "A double-blind, placebo-controlled trial of tiagabine for the treatment of cocaine dependence",

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 1 h 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.",

keywords = "Clinical trial, Cocaine dependence, Double-blind, Tiagabine",

author = "Theresa Winhusen and Eugene Somoza and Ciraulo, {Domenic A.} and Harrer, {Judy M.} and Goldsmith, {R. Jeffrey} and John Grabowski and Coleman, {Florence S.} and Gordon Mindrum and Roberta Kahn and Sabuhi Osman and Juris Mezinskis and Li, {Shou Hua} and Daniel Lewis and Paul Horn and Montgomery, {Margaret A.} and Ahmed Elkashef",

note = "Funding Information: This study was supported by the National Institutes of Health, National Institute on Drug Abuse through contract N01-DA-9-8095 (E. Somoza). The study medication and matching placebo were provided by Cephalon at no cost. Dr. Ciraulo has served as a consultant for Alkermes, Astra Zeneca, Bristol Myers Squibb, Cephalon, Johnson & Johnson, Ortho-McNeil, and UCB Pharma. We thank the faculty and staff at the study sites for their contributions to this project. In particular we wish to thank Jacqueline Carter, B.S., Cindy Schulze, B.A., Rachel Heffield, B.A., Daniel Owens, L.S.W., Ron Coleman, B.A., Eva Moore, Julie Jansen, B.A., Cathy Otto, M.A., Barbara Thomas, M.A., Daniel Alfaro, M.D. We thank Gerardo Gonz{\'a}lez, M.D. for his assistance in reproducing his primary analysis with our study data.",

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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

N1 - Funding Information: This study was supported by the National Institutes of Health, National Institute on Drug Abuse through contract N01-DA-9-8095 (E. Somoza). The study medication and matching placebo were provided by Cephalon at no cost. Dr. Ciraulo has served as a consultant for Alkermes, Astra Zeneca, Bristol Myers Squibb, Cephalon, Johnson & Johnson, Ortho-McNeil, and UCB Pharma. We thank the faculty and staff at the study sites for their contributions to this project. In particular we wish to thank Jacqueline Carter, B.S., Cindy Schulze, B.A., Rachel Heffield, B.A., Daniel Owens, L.S.W., Ron Coleman, B.A., Eva Moore, Julie Jansen, B.A., Cathy Otto, M.A., Barbara Thomas, M.A., Daniel Alfaro, M.D. We thank Gerardo González, M.D. for his assistance in reproducing his primary analysis with our study data.

PY - 2007/12/1

Y1 - 2007/12/1

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 1 h 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.

AB - 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 1 h 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.

KW - Clinical trial

KW - Cocaine dependence

KW - Double-blind

KW - Tiagabine

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A double-blind, placebo-controlled trial of tiagabine for the treatment of cocaine dependence

Abstract

Bibliographical note

Keywords

UN SDGs

Publisher link

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