Topiramate-phentermine combinations reduce cocaine self-administration in humans
•Topiramate-phentermine combinations significantly reduced cocaine self-administration in humans.•All of the topiramate-phentermine combinations were well tolerated alone and in conjunction with cocaine.•Future clinical trials should determine the efficacy of topiramate-phentermine combinations for...
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| Published in: | Drug and alcohol dependence Vol. 218; p. 108413 |
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| Format: | Journal Article |
| Language: | English |
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| Abstract | •Topiramate-phentermine combinations significantly reduced cocaine self-administration in humans.•All of the topiramate-phentermine combinations were well tolerated alone and in conjunction with cocaine.•Future clinical trials should determine the efficacy of topiramate-phentermine combinations for cocaine use disorder.
Cocaine use disorder is an unrelenting public health concern. Despite nearly four decades of research, an FDA approved medication is not yet available.
The objective of this human laboratory study was to demonstrate the initial efficacy, safety and tolerability of topiramate-phentermine combinations for cocaine use disorder.
Thirty-one (31) participants with cocaine use disorder completed this mixed-model inpatient laboratory study. Participants were maintained on topiramate (0 [N = 11], 50 [N = 9] or 100 [N = 11] mg/day). Each topiramate group was concurrently maintained on phentermine (0, 15, 30 mg). Drug self-administration, subjective responses and cardiovascular effects following acute doses of intranasal cocaine (0, 40, 80 mg) were determined during separate experimental sessions after at least seven (7) days of maintenance on each condition.
The three groups of participants were well matched demographically and generally did not differ significantly in their responses to a range of doses of intranasal cocaine (0, 10, 20, 40, 80 mg) during a medical safety session. Maintenance on topiramate and phentermine alone significantly decreased cocaine self-administration although these effects were modest in magnitude. Combining topiramate and phentermine robustly decreased cocaine self-administration. Topiramate and phentermine were well tolerated alone and combined, as well as in conjunction with cocaine.
The results of the present study support advancing topiramate-phentermine combinations as a putative pharmacotherapeutic for cocaine use disorder. |
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| AbstractList | RATIONALECocaine use disorder is an unrelenting public health concern. Despite nearly four decades of research, an FDA approved medication is not yet available. OBJECTIVESThe objective of this human laboratory study was to demonstrate the initial efficacy, safety and tolerability of topiramate-phentermine combinations for cocaine use disorder. METHODSThirty-one (31) participants with cocaine use disorder completed this mixed-model inpatient laboratory study. Participants were maintained on topiramate (0 [N = 11], 50 [N = 9] or 100 [N = 11] mg/day). Each topiramate group was concurrently maintained on phentermine (0, 15, 30 mg). Drug self-administration, subjective responses and cardiovascular effects following acute doses of intranasal cocaine (0, 40, 80 mg) were determined during separate experimental sessions after at least seven (7) days of maintenance on each condition. RESULTSThe three groups of participants were well matched demographically and generally did not differ significantly in their responses to a range of doses of intranasal cocaine (0, 10, 20, 40, 80 mg) during a medical safety session. Maintenance on topiramate and phentermine alone significantly decreased cocaine self-administration although these effects were modest in magnitude. Combining topiramate and phentermine robustly decreased cocaine self-administration. Topiramate and phentermine were well tolerated alone and combined, as well as in conjunction with cocaine. CONCLUSIONSThe results of the present study support advancing topiramate-phentermine combinations as a putative pharmacotherapeutic for cocaine use disorder. •Topiramate-phentermine combinations significantly reduced cocaine self-administration in humans.•All of the topiramate-phentermine combinations were well tolerated alone and in conjunction with cocaine.•Future clinical trials should determine the efficacy of topiramate-phentermine combinations for cocaine use disorder. Cocaine use disorder is an unrelenting public health concern. Despite nearly four decades of research, an FDA approved medication is not yet available. The objective of this human laboratory study was to demonstrate the initial efficacy, safety and tolerability of topiramate-phentermine combinations for cocaine use disorder. Thirty-one (31) participants with cocaine use disorder completed this mixed-model inpatient laboratory study. Participants were maintained on topiramate (0 [N = 11], 50 [N = 9] or 100 [N = 11] mg/day). Each topiramate group was concurrently maintained on phentermine (0, 15, 30 mg). Drug self-administration, subjective responses and cardiovascular effects following acute doses of intranasal cocaine (0, 40, 80 mg) were determined during separate experimental sessions after at least seven (7) days of maintenance on each condition. The three groups of participants were well matched demographically and generally did not differ significantly in their responses to a range of doses of intranasal cocaine (0, 10, 20, 40, 80 mg) during a medical safety session. Maintenance on topiramate and phentermine alone significantly decreased cocaine self-administration although these effects were modest in magnitude. Combining topiramate and phentermine robustly decreased cocaine self-administration. Topiramate and phentermine were well tolerated alone and combined, as well as in conjunction with cocaine. The results of the present study support advancing topiramate-phentermine combinations as a putative pharmacotherapeutic for cocaine use disorder. Rationale: Cocaine use disorder is an unrelenting public health concern. Despite nearly four decades of research, an FDA approved medication is not yet available. Objectives: The objective of this human laboratory study was to demonstrate the initial efficacy, safety and tolerability of topiramate-phentermine combinations for cocaine use disorder. Methods: Thirty-one (31) participants with cocaine use disorder completed this mixed-model inpatient laboratory study. Participants were maintained on topiramate (0 [N = 11], 50 [N = 9] or 100 [N = 11] mg/day). Each topiramate group was concurrently maintained on phentermine (0, 15, 30 mg). Drug self-administration, subjective responses and cardiovascular effects following acute doses of intranasal cocaine (0, 40, 80 mg) were determined during separate experimental sessions after at least seven (7) days of maintenance on each condition. Results: The three groups of participants were well matched demographically and generally did not differ significantly in their responses to a range of doses of intranasal cocaine (0, 10, 20, 40, 80 mg) during a medical safety session. Maintenance on topiramate and phentermine alone significantly decreased cocaine self-administration although these effects were modest in magnitude. Combining topiramate and phentermine robustly decreased cocaine self-administration. Topiramate and phentermine were well tolerated alone and combined, as well as in conjunction with cocaine. Conclusions: The results of the present study support advancing topiramate-phentermine combinations as a putative pharmacotherapeutic for cocaine use disorder. Cocaine use disorder is an unrelenting public health concern. Despite nearly four decades of research, an FDA approved medication is not yet available. The objective of this human laboratory study was to demonstrate the initial efficacy, safety and tolerability of topiramate-phentermine combinations for cocaine use disorder. Thirty-one (31) participants with cocaine use disorder completed this mixed-model inpatient laboratory study. Participants were maintained on topiramate (0 [N = 11], 50 [N = 9] or 100 [N = 11] mg/day). Each topiramate group was concurrently maintained on phentermine (0, 15, 30 mg). Drug self-administration, subjective responses and cardiovascular effects following acute doses of intranasal cocaine (0, 40, 80 mg) were determined during separate experimental sessions after at least seven (7) days of maintenance on each condition. The three groups of participants were well matched demographically and generally did not differ significantly in their responses to a range of doses of intranasal cocaine (0, 10, 20, 40, 80 mg) during a medical safety session. Maintenance on topiramate and phentermine alone significantly decreased cocaine self-administration although these effects were modest in magnitude. Combining topiramate and phentermine robustly decreased cocaine self-administration. Topiramate and phentermine were well tolerated alone and combined, as well as in conjunction with cocaine. The results of the present study support advancing topiramate-phentermine combinations as a putative pharmacotherapeutic for cocaine use disorder. |
| ArticleNumber | 108413 |
| Author | Hays, Lon R. Alcorn, Joseph L. Rush, Craig R. Stoops, William W. Lile, Joshua A. Bolin, B. Levi Rayapati, Abner O. Reynolds, Anna R. |
| Author_xml | – sequence: 1 givenname: Craig R. surname: Rush fullname: Rush, Craig R. email: crush2@email.uky.edu organization: Department of Behavioral Science, University of Kentucky College of Medicine, 1100 Veterans Drive, Medical Behavioral Science Building, Lexington, KY, 40536-0086, USA – sequence: 2 givenname: William W. surname: Stoops fullname: Stoops, William W. organization: Department of Behavioral Science, University of Kentucky College of Medicine, 1100 Veterans Drive, Medical Behavioral Science Building, Lexington, KY, 40536-0086, USA – sequence: 3 givenname: Joshua A. surname: Lile fullname: Lile, Joshua A. organization: Department of Behavioral Science, University of Kentucky College of Medicine, 1100 Veterans Drive, Medical Behavioral Science Building, Lexington, KY, 40536-0086, USA – sequence: 4 givenname: Joseph L. surname: Alcorn fullname: Alcorn, Joseph L. organization: Department of Behavioral Science, University of Kentucky College of Medicine, 1100 Veterans Drive, Medical Behavioral Science Building, Lexington, KY, 40536-0086, USA – sequence: 5 givenname: B. Levi surname: Bolin fullname: Bolin, B. Levi organization: Department of Behavioral Science, University of Kentucky College of Medicine, 1100 Veterans Drive, Medical Behavioral Science Building, Lexington, KY, 40536-0086, USA – sequence: 6 givenname: Anna R. surname: Reynolds fullname: Reynolds, Anna R. organization: Department of Behavioral Science, University of Kentucky College of Medicine, 1100 Veterans Drive, Medical Behavioral Science Building, Lexington, KY, 40536-0086, USA – sequence: 7 givenname: Lon R. surname: Hays fullname: Hays, Lon R. organization: Department of Psychiatry, University of Kentucky College of Medicine, 245 Fountain Court, Lexington, KY, 40509-1810, USA – sequence: 8 givenname: Abner O. surname: Rayapati fullname: Rayapati, Abner O. organization: Department of Psychiatry, University of Kentucky College of Medicine, 245 Fountain Court, Lexington, KY, 40509-1810, USA |
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| Snippet | •Topiramate-phentermine combinations significantly reduced cocaine self-administration in humans.•All of the topiramate-phentermine combinations were well... Cocaine use disorder is an unrelenting public health concern. Despite nearly four decades of research, an FDA approved medication is not yet available. The... Rationale: Cocaine use disorder is an unrelenting public health concern. Despite nearly four decades of research, an FDA approved medication is not yet... RATIONALECocaine use disorder is an unrelenting public health concern. Despite nearly four decades of research, an FDA approved medication is not yet... |
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| SubjectTerms | Cardiovascular system Cocaine Dosage Drug self-administration Drugs Efficacy Humans Inpatient care Laboratories Maintenance Management Nasal sprays Pharmacotherapy Phentermine Public health Safety Self-administration Topiramate |
| Title | Topiramate-phentermine combinations reduce cocaine self-administration in humans |
| URI | https://dx.doi.org/10.1016/j.drugalcdep.2020.108413 https://www.ncbi.nlm.nih.gov/pubmed/33290875 https://www.proquest.com/docview/2488255424 https://search.proquest.com/docview/2468670357 |
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