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| ID | Type | Description | Link |
|---|---|---|---|
| P50DA009262 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The purpose of this research study is to determine whether a medication called pioglitazone (trade name Actos) can reduce behavioral problems associated with cocaine use, improve brain structural changes associated with cocaine use and reduce cocaine craving and drug use in cocaine dependent patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pioglitazone + Therapy + Contingency Management | Experimental | Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued. |
|
| Placebo + Therapy + Contingency Management | Placebo Comparator | Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pioglitazone | Drug | Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued. |
| Measure | Description | Time Frame |
|---|---|---|
| Craving as Assessed by the Brief Substance Craving Scale (BSCS) | The brief substance craving scale (BSCS) is a 16-item, self-report instrument assesses craving for cocaine and other substances of abuse over a 24 hour period. The domains of intensity, frequency, and duration are recorded on a five-point Likert scale. The range of scores for each domain is 0 to 4, and the total score is the sum of all three domains. The total score range is 0 to 12, and higher scores indicate higher craving (worse outcome.) | Baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12 |
| Craving as Assessed by the Obsessive Compulsive Drug Use Scale (OCDUS) | The obsessive compulsive drug use scale (OCDUS) measures the level of craving for cocaine during the past week. The mean score over all time points is reported in this outcome measure (i.e., a summary score is reported). The scale was administered once weekly. It consists of 12 items. The score range is 0 to 60, and higher scores indicates greater craving. | Weeks 1-12 |
| Cue Reactivity as Assessed by a Visual Analogue Scale (VAS) of Cocaine Craving | Every two weeks, visual analog scale ratings of craving (VAS craving) consisting of 100 mm line, anchored by 0 "not at all" and 100 "extremely," were used to assess cocaine craving right now, craving on average in the past week, and the worst craving in the past week. Data were analyzed as a total score, which is the sum of the scores for the three questions. | Baseline, week 2, week 4, week 6, week 8, week 10, week 12 |
| Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Posterior Thalamic Radiation) | DTI scans were acquired on a Philips Integra 3T magnet. Fractional anisotropy (FA) is a summary measure of the integrity of white matter neurons that provides a dimensionless index of the expected movement of water molecules inside and across the neuron. Higher values of FA indicate better neuronal integrity (that is, less movement of water across the neuron). There is no range of values, as this is a dimensionless index. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility - Subject Retention as Assessed by Number of Participants Who Completed All 12 Weeks of the Study | week 12 | |
| Feasibility - Medication Compliance as Assessed by Percentage of Urine Samples That Were Riboflavin-Positive | Riboflavin was added to pill capsules as a marker of medication compliance. The percentage over all time points is reported in this outcome measure. Urine samples were collected once weekly. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joy M Schmitz, PhD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pioglitazone + Therapy + Contingency Management | Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued. Therapy: Cognitive-behavioral therapy 1 hour per week Contingency Management: Prize-based contingency management for attendance |
| FG001 | Placebo + Therapy + Contingency Management | Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study. Therapy: Cognitive-behavioral therapy 1 hour per week Contingency Management: Prize-based contingency management for attendance |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pioglitazone + Therapy + Contingency Management | Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued. Therapy: Cognitive-behavioral therapy 1 hour per week Contingency Management: Prize-based contingency management for attendance |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Craving as Assessed by the Brief Substance Craving Scale (BSCS) | The brief substance craving scale (BSCS) is a 16-item, self-report instrument assesses craving for cocaine and other substances of abuse over a 24 hour period. The domains of intensity, frequency, and duration are recorded on a five-point Likert scale. The range of scores for each domain is 0 to 4, and the total score is the sum of all three domains. The total score range is 0 to 12, and higher scores indicate higher craving (worse outcome.) | Posted | Mean | Standard Deviation | units on a scale | Baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12 |
|
12 weeks
Side effects are listed in Outcome Measure 13 are side effects; however, side effects were not considered to be adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pioglitazone + Therapy + Contingency Management | Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued. Therapy: Cognitive-behavioral therapy 1 hour per week Contingency Management: Prize-based contingency management for attendance |
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Small sample size; restricted measurement battery; comorbid CUD & AUD; single dose; for DTI, Bayesian parameter estimates of variance in the simple effects may be underestimated; generalizability of pioglitazone to other substances of abuse unknown.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joy M. Schmitz, PhD | The University of Texas Health Science Center at Houston | 713-486-2867 | Joy.M.Schmitz@uth.tmc.edu |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| D013213 | Starch |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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|
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| Placebo | Drug | Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study. |
|
|
| Therapy | Behavioral | Cognitive-behavioral therapy 1 hour per week |
|
| Contingency Management | Behavioral | Prize-based contingency management for attendance |
|
| Baseline and Week 12 |
| Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Anterior Thalamic Radiation) | DTI scans were acquired on a Philips Integra 3T magnet. Fractional anisotropy (FA) is a summary measure of the integrity of white matter neurons that provides a dimensionless index of the expected movement of water molecules inside and across the neuron. Higher values of FA indicate better neuronal integrity (that is, less movement of water across the neuron). There is no range of values, as this is a dimensionless index. | Baseline and Week 12 |
| Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Splenium of Corpus Callosum) | DTI scans were acquired on a Philips Integra 3T magnet. Fractional anisotropy (FA) is a summary measure of the integrity of white matter neurons that provides a dimensionless index of the expected movement of water molecules inside and across the neuron. Higher values of FA indicate better neuronal integrity (that is, less movement of water across the neuron). There is no range of values, as this is a dimensionless index. | Baseline and Week 12 |
| Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Genu of Corpus Callosum) | DTI scans were acquired on a Philips Integra 3T magnet. Fractional anisotropy (FA) is a summary measure of the integrity of white matter neurons that provides a dimensionless index of the expected movement of water molecules inside and across the neuron. Higher values of FA indicate better neuronal integrity (that is, less movement of water across the neuron). There is no range of values, as this is a dimensionless index. | Baseline and Week 12 |
| Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - External Capsule) | DTI scans were acquired on a Philips Integra 3T magnet. Fractional anisotropy (FA) is a summary measure of the integrity of white matter neurons that provides a dimensionless index of the expected movement of water molecules inside and across the neuron. Higher values of FA indicate better neuronal integrity (that is, less movement of water across the neuron). There is no range of values, as this is a dimensionless index. | Baseline and Week 12 |
| Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Cingulum) | DTI scans were acquired on a Philips Integra 3T magnet. Fractional anisotropy (FA) is a summary measure of the integrity of white matter neurons that provides a dimensionless index of the expected movement of water molecules inside and across the neuron. Higher values of FA indicate better neuronal integrity (that is, less movement of water across the neuron). There is no range of values, as this is a dimensionless index. | Baseline and Week 12 |
| weeks 1 - 12 |
| Feasibility - Medication Compliance as Assessed by Percentage of Self-reports That Indicate Capsules Were Taken | A modified Timeline Followback (TLFB) procedure was used for self-reports. The percentage over all time points is reported in this outcome measure. Self-reports were collected once weekly. | weeks 1 - 12 |
| Feasibility - Tolerability as Assessed by Number of Participants Reporting Side Effects | week 12 |
| Feasibility - Tolerability as Assessed by Number of Participants With Serious Adverse Events | week 12 |
| Cocaine Use as Assessed by Percentage of Urine Samples That Were Cocaine-positive | The mean percentage over all time points is reported in this outcome measure. Urine samples were collected once weekly. | Weeks 1-12 |
| Cocaine Use as Assessed by Percentage of Self-reports That Indicate Cocaine Use | A modified Timeline Followback (TLFB) procedure was used to assess cocaine use. The mean percentage over all time points is reported in this outcome measure. Self-reports were collected once weekly. | Weeks 1-12 |
| BG001 | Placebo + Therapy + Contingency Management | Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study. Therapy: Cognitive-behavioral therapy 1 hour per week Contingency Management: Prize-based contingency management for attendance |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Placebo + Therapy + Contingency Management | Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study. Therapy: Cognitive-behavioral therapy 1 hour per week Contingency Management: Prize-based contingency management for attendance |
|
|
| Primary | Craving as Assessed by the Obsessive Compulsive Drug Use Scale (OCDUS) | The obsessive compulsive drug use scale (OCDUS) measures the level of craving for cocaine during the past week. The mean score over all time points is reported in this outcome measure (i.e., a summary score is reported). The scale was administered once weekly. It consists of 12 items. The score range is 0 to 60, and higher scores indicates greater craving. | Posted | Mean | Standard Deviation | units on a scale | Weeks 1-12 |
|
|
|
| Primary | Cue Reactivity as Assessed by a Visual Analogue Scale (VAS) of Cocaine Craving | Every two weeks, visual analog scale ratings of craving (VAS craving) consisting of 100 mm line, anchored by 0 "not at all" and 100 "extremely," were used to assess cocaine craving right now, craving on average in the past week, and the worst craving in the past week. Data were analyzed as a total score, which is the sum of the scores for the three questions. | Posted | Mean | Standard Deviation | units on a scale | Baseline, week 2, week 4, week 6, week 8, week 10, week 12 |
|
|
|
| Primary | Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Posterior Thalamic Radiation) | DTI scans were acquired on a Philips Integra 3T magnet. Fractional anisotropy (FA) is a summary measure of the integrity of white matter neurons that provides a dimensionless index of the expected movement of water molecules inside and across the neuron. Higher values of FA indicate better neuronal integrity (that is, less movement of water across the neuron). There is no range of values, as this is a dimensionless index. | Although 21 completed the study, only 18 were analyzed for this measure. This is because DTI FA data was collected for only 18 subjects. Reasons for not completing DTI: 1 subject had a brain abnormality; 1 subject refused to do the scan; and 1 scan was not completed due to scanner shutdown for maintenance. | Posted | Mean | Standard Deviation | DTI Fractional Anisotropy (FA) value | Baseline and Week 12 |
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| Primary | Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Anterior Thalamic Radiation) | DTI scans were acquired on a Philips Integra 3T magnet. Fractional anisotropy (FA) is a summary measure of the integrity of white matter neurons that provides a dimensionless index of the expected movement of water molecules inside and across the neuron. Higher values of FA indicate better neuronal integrity (that is, less movement of water across the neuron). There is no range of values, as this is a dimensionless index. | Although 21 completed the study, only 18 were analyzed for this measure. This is because DTI FA data was collected for only 18 subjects. Reasons for not completing DTI: 1 subject had a brain abnormality; 1 subject refused to do the scan; and 1 scan was not completed due to scanner shutdown for maintenance. | Posted | Mean | Standard Deviation | DTI Fractional Anisotropy (FA) value | Baseline and Week 12 |
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| Primary | Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Splenium of Corpus Callosum) | DTI scans were acquired on a Philips Integra 3T magnet. Fractional anisotropy (FA) is a summary measure of the integrity of white matter neurons that provides a dimensionless index of the expected movement of water molecules inside and across the neuron. Higher values of FA indicate better neuronal integrity (that is, less movement of water across the neuron). There is no range of values, as this is a dimensionless index. | Although 21 completed the study, only 18 were analyzed for this measure. This is because DTI FA data was collected for only 18 subjects. Reasons for not completing DTI: 1 subject had a brain abnormality; 1 subject refused to do the scan; and 1 scan was not completed due to scanner shutdown for maintenance. | Posted | Mean | Standard Deviation | DTI Fractional Anisotropy (FA) value | Baseline and Week 12 |
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| Primary | Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Genu of Corpus Callosum) | DTI scans were acquired on a Philips Integra 3T magnet. Fractional anisotropy (FA) is a summary measure of the integrity of white matter neurons that provides a dimensionless index of the expected movement of water molecules inside and across the neuron. Higher values of FA indicate better neuronal integrity (that is, less movement of water across the neuron). There is no range of values, as this is a dimensionless index. | Although 21 completed the study, only 18 were analyzed for this measure. This is because DTI FA data was collected for only 18 subjects. Reasons for not completing DTI: 1 subject had a brain abnormality; 1 subject refused to do the scan; and 1 scan was not completed due to scanner shutdown for maintenance. | Posted | Mean | Standard Deviation | DTI Fractional Anisotropy (FA) value | Baseline and Week 12 |
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| Primary | Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - External Capsule) | DTI scans were acquired on a Philips Integra 3T magnet. Fractional anisotropy (FA) is a summary measure of the integrity of white matter neurons that provides a dimensionless index of the expected movement of water molecules inside and across the neuron. Higher values of FA indicate better neuronal integrity (that is, less movement of water across the neuron). There is no range of values, as this is a dimensionless index. | Although 21 completed the study, only 18 were analyzed for this measure. This is because DTI FA data was collected for only 18 subjects. Reasons for not completing DTI: 1 subject had a brain abnormality; 1 subject refused to do the scan; and 1 scan was not completed due to scanner shutdown for maintenance. | Posted | Mean | Standard Deviation | DTI Fractional Anisotropy (FA) value | Baseline and Week 12 |
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| Primary | Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Cingulum) | DTI scans were acquired on a Philips Integra 3T magnet. Fractional anisotropy (FA) is a summary measure of the integrity of white matter neurons that provides a dimensionless index of the expected movement of water molecules inside and across the neuron. Higher values of FA indicate better neuronal integrity (that is, less movement of water across the neuron). There is no range of values, as this is a dimensionless index. | Although 21 completed the study, only 18 were analyzed for this measure. This is because DTI FA data was collected for only 18 subjects. Reasons for not completing DTI: 1 subject had a brain abnormality; 1 subject refused to do the scan; and 1 scan was not completed due to scanner shutdown for maintenance. | Posted | Mean | Standard Deviation | DTI Fractional Anisotropy (FA) value | Baseline and Week 12 |
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| Secondary | Feasibility - Subject Retention as Assessed by Number of Participants Who Completed All 12 Weeks of the Study | Posted | Count of Participants | Participants | week 12 |
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| Secondary | Feasibility - Medication Compliance as Assessed by Percentage of Urine Samples That Were Riboflavin-Positive | Riboflavin was added to pill capsules as a marker of medication compliance. The percentage over all time points is reported in this outcome measure. Urine samples were collected once weekly. | Posted | Mean | Standard Error | percentage of urine samples | weeks 1 - 12 |
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| Secondary | Feasibility - Medication Compliance as Assessed by Percentage of Self-reports That Indicate Capsules Were Taken | A modified Timeline Followback (TLFB) procedure was used for self-reports. The percentage over all time points is reported in this outcome measure. Self-reports were collected once weekly. | Posted | Mean | Standard Error | percentage of self-reports | weeks 1 - 12 |
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| Secondary | Feasibility - Tolerability as Assessed by Number of Participants Reporting Side Effects | Posted | Count of Participants | Participants | week 12 |
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| Secondary | Feasibility - Tolerability as Assessed by Number of Participants With Serious Adverse Events | Posted | Count of Participants | Participants | week 12 |
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| Secondary | Cocaine Use as Assessed by Percentage of Urine Samples That Were Cocaine-positive | The mean percentage over all time points is reported in this outcome measure. Urine samples were collected once weekly. | Posted | Mean | Standard Deviation | percentage of urine samples | Weeks 1-12 |
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| Secondary | Cocaine Use as Assessed by Percentage of Self-reports That Indicate Cocaine Use | A modified Timeline Followback (TLFB) procedure was used to assess cocaine use. The mean percentage over all time points is reported in this outcome measure. Self-reports were collected once weekly. | Posted | Mean | Standard Deviation | percentage of self-reports | Weeks 1-12 |
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|
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Placebo + Therapy + Contingency Management | Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study. Therapy: Cognitive-behavioral therapy 1 hour per week Contingency Management: Prize-based contingency management for attendance | 0 | 14 | 0 | 14 |
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| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011134 | Polysaccharides |
| week 4 |
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| week 6 |
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| week 8 |
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| week 10 |
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| week 12 |
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| headache |
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| nervousness |
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| blurry vision |
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| dizziness |
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| nausea |
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| vomiting |
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| diarrhea |
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| stomach pain |
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| muscle aches |
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| shortness of breath |
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| cough |
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| increased urination |
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| change in sexual function |
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| weakness |
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| fatigue |
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| difficulty walking |
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| fever or chills |
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| loss of appetite |
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| confusion |
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| cloudiness |
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| memory loss |
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