Trial Outcomes & Findings for PPARγ Agonist Treatment for Cocaine Dependence (NCT NCT02774343)
NCT ID: NCT02774343
Last Updated: 2018-04-26
Results Overview
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.)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
30 participants
Primary outcome timeframe
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
Results posted on
2018-04-26
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
Received at Least One Capsule
|
12
|
14
|
|
Overall Study
COMPLETED
|
9
|
12
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PPARγ Agonist Treatment for Cocaine Dependence
Baseline characteristics by cohort
| Measure |
Pioglitazone + Therapy + Contingency Management
n=15 Participants
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
|
Placebo + Therapy + Contingency Management
n=15 Participants
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
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.3 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
47.4 years
STANDARD_DEVIATION 7.8 • n=7 Participants
|
47.8 years
STANDARD_DEVIATION 7.45 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12The 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.)
Outcome measures
| Measure |
Pioglitazone + Therapy + Contingency Management
n=12 Participants
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
|
Placebo + Therapy + Contingency Management
n=14 Participants
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
|
|---|---|---|
|
Craving as Assessed by the Brief Substance Craving Scale (BSCS)
baseline
|
5.57 units on a scale
Standard Deviation 2.47
|
6.23 units on a scale
Standard Deviation 3.30
|
|
Craving as Assessed by the Brief Substance Craving Scale (BSCS)
week 1
|
5.00 units on a scale
Standard Deviation 3.36
|
5.08 units on a scale
Standard Deviation 3.06
|
|
Craving as Assessed by the Brief Substance Craving Scale (BSCS)
week 2
|
4.42 units on a scale
Standard Deviation 2.11
|
2.91 units on a scale
Standard Deviation 2.55
|
|
Craving as Assessed by the Brief Substance Craving Scale (BSCS)
week 3
|
4.00 units on a scale
Standard Deviation 3.33
|
3.82 units on a scale
Standard Deviation 3.89
|
|
Craving as Assessed by the Brief Substance Craving Scale (BSCS)
week 4
|
4.00 units on a scale
Standard Deviation 3.16
|
3.18 units on a scale
Standard Deviation 2.75
|
|
Craving as Assessed by the Brief Substance Craving Scale (BSCS)
week 5
|
2.60 units on a scale
Standard Deviation 2.55
|
3.82 units on a scale
Standard Deviation 2.79
|
|
Craving as Assessed by the Brief Substance Craving Scale (BSCS)
week 6
|
3.22 units on a scale
Standard Deviation 2.78
|
3.45 units on a scale
Standard Deviation 3.39
|
|
Craving as Assessed by the Brief Substance Craving Scale (BSCS)
week 7
|
2.12 units on a scale
Standard Deviation 1.64
|
4.36 units on a scale
Standard Deviation 3.14
|
|
Craving as Assessed by the Brief Substance Craving Scale (BSCS)
week 8
|
3.25 units on a scale
Standard Deviation 2.12
|
3.55 units on a scale
Standard Deviation 2.38
|
|
Craving as Assessed by the Brief Substance Craving Scale (BSCS)
week 9
|
2.88 units on a scale
Standard Deviation 2.53
|
3.82 units on a scale
Standard Deviation 3.25
|
|
Craving as Assessed by the Brief Substance Craving Scale (BSCS)
week 10
|
2.56 units on a scale
Standard Deviation 2.55
|
3.36 units on a scale
Standard Deviation 2.98
|
|
Craving as Assessed by the Brief Substance Craving Scale (BSCS)
week 11
|
2.89 units on a scale
Standard Deviation 2.62
|
3.82 units on a scale
Standard Deviation 2.56
|
|
Craving as Assessed by the Brief Substance Craving Scale (BSCS)
week 12
|
2.00 units on a scale
Standard Deviation 2.39
|
3.55 units on a scale
Standard Deviation 2.88
|
PRIMARY outcome
Timeframe: Weeks 1-12The 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.
Outcome measures
| Measure |
Pioglitazone + Therapy + Contingency Management
n=12 Participants
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
|
Placebo + Therapy + Contingency Management
n=14 Participants
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
|
|---|---|---|
|
Craving as Assessed by the Obsessive Compulsive Drug Use Scale (OCDUS)
|
19.1 units on a scale
Standard Deviation 3.5
|
21.36 units on a scale
Standard Deviation 8.7
|
PRIMARY outcome
Timeframe: Baseline, week 2, week 4, week 6, week 8, week 10, week 12Every 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.
Outcome measures
| Measure |
Pioglitazone + Therapy + Contingency Management
n=12 Participants
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
|
Placebo + Therapy + Contingency Management
n=14 Participants
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
|
|---|---|---|
|
Cue Reactivity as Assessed by a Visual Analogue Scale (VAS) of Cocaine Craving
baseline
|
57.50 units on a scale
Standard Deviation 22.83
|
52.29 units on a scale
Standard Deviation 29.49
|
|
Cue Reactivity as Assessed by a Visual Analogue Scale (VAS) of Cocaine Craving
week 2
|
53.76 units on a scale
Standard Deviation 23.10
|
40.31 units on a scale
Standard Deviation 29.38
|
|
Cue Reactivity as Assessed by a Visual Analogue Scale (VAS) of Cocaine Craving
week 4
|
37.93 units on a scale
Standard Deviation 22.30
|
35.58 units on a scale
Standard Deviation 29.00
|
|
Cue Reactivity as Assessed by a Visual Analogue Scale (VAS) of Cocaine Craving
week 6
|
21.75 units on a scale
Standard Deviation 22.97
|
29.86 units on a scale
Standard Deviation 31.27
|
|
Cue Reactivity as Assessed by a Visual Analogue Scale (VAS) of Cocaine Craving
week 8
|
25.70 units on a scale
Standard Deviation 23.34
|
35.88 units on a scale
Standard Deviation 34.20
|
|
Cue Reactivity as Assessed by a Visual Analogue Scale (VAS) of Cocaine Craving
week 10
|
18.33 units on a scale
Standard Deviation 24.38
|
31.42 units on a scale
Standard Deviation 35.61
|
|
Cue Reactivity as Assessed by a Visual Analogue Scale (VAS) of Cocaine Craving
week 12
|
15.38 units on a scale
Standard Deviation 28.91
|
27.86 units on a scale
Standard Deviation 30.20
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: 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.
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.
Outcome measures
| Measure |
Pioglitazone + Therapy + Contingency Management
n=8 Participants
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
|
Placebo + Therapy + Contingency Management
n=10 Participants
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
|
|---|---|---|
|
Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Posterior Thalamic Radiation)
baseline
|
542.27 DTI Fractional Anisotropy (FA) value
Standard Deviation 24.60
|
546.26 DTI Fractional Anisotropy (FA) value
Standard Deviation 27.02
|
|
Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Posterior Thalamic Radiation)
week 12
|
546.84 DTI Fractional Anisotropy (FA) value
Standard Deviation 32.79
|
535.14 DTI Fractional Anisotropy (FA) value
Standard Deviation 27.61
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: 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.
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.
Outcome measures
| Measure |
Pioglitazone + Therapy + Contingency Management
n=8 Participants
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
|
Placebo + Therapy + Contingency Management
n=10 Participants
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
|
|---|---|---|
|
Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Anterior Thalamic Radiation)
baseline
|
518.20 DTI Fractional Anisotropy (FA) value
Standard Deviation 24.42
|
530.31 DTI Fractional Anisotropy (FA) value
Standard Deviation 26.28
|
|
Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Anterior Thalamic Radiation)
week 12
|
522.40 DTI Fractional Anisotropy (FA) value
Standard Deviation 30.85
|
523.00 DTI Fractional Anisotropy (FA) value
Standard Deviation 36.46
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: 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.
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.
Outcome measures
| Measure |
Pioglitazone + Therapy + Contingency Management
n=8 Participants
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
|
Placebo + Therapy + Contingency Management
n=10 Participants
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
|
|---|---|---|
|
Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Splenium of Corpus Callosum)
baseline
|
645.49 DTI Fractional Anisotropy (FA) value
Standard Deviation 48.82
|
635.81 DTI Fractional Anisotropy (FA) value
Standard Deviation 26.26
|
|
Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Splenium of Corpus Callosum)
week 12
|
655.41 DTI Fractional Anisotropy (FA) value
Standard Deviation 26.73
|
620.98 DTI Fractional Anisotropy (FA) value
Standard Deviation 35.51
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: 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.
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.
Outcome measures
| Measure |
Pioglitazone + Therapy + Contingency Management
n=8 Participants
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
|
Placebo + Therapy + Contingency Management
n=10 Participants
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
|
|---|---|---|
|
Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Genu of Corpus Callosum)
baseline
|
566.66 DTI Fractional Anisotropy (FA) value
Standard Deviation 44.18
|
562.52 DTI Fractional Anisotropy (FA) value
Standard Deviation 29.34
|
|
Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Genu of Corpus Callosum)
week 12
|
575.06 DTI Fractional Anisotropy (FA) value
Standard Deviation 30.78
|
547.15 DTI Fractional Anisotropy (FA) value
Standard Deviation 37.45
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: 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.
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.
Outcome measures
| Measure |
Pioglitazone + Therapy + Contingency Management
n=8 Participants
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
|
Placebo + Therapy + Contingency Management
n=10 Participants
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
|
|---|---|---|
|
Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - External Capsule)
week 12
|
423.91 DTI Fractional Anisotropy (FA) value
Standard Deviation 17.23
|
418.25 DTI Fractional Anisotropy (FA) value
Standard Deviation 16.98
|
|
Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - External Capsule)
baseline
|
420.68 DTI Fractional Anisotropy (FA) value
Standard Deviation 22.35
|
418.71 DTI Fractional Anisotropy (FA) value
Standard Deviation 15.92
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: 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.
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.
Outcome measures
| Measure |
Pioglitazone + Therapy + Contingency Management
n=8 Participants
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
|
Placebo + Therapy + Contingency Management
n=10 Participants
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
|
|---|---|---|
|
Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Cingulum)
baseline
|
465.06 DTI Fractional Anisotropy (FA) value
Standard Deviation 22.35
|
463.91 DTI Fractional Anisotropy (FA) value
Standard Deviation 15.92
|
|
Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Cingulum)
week 12
|
471.40 DTI Fractional Anisotropy (FA) value
Standard Deviation 17.23
|
465.75 DTI Fractional Anisotropy (FA) value
Standard Deviation 16.98
|
SECONDARY outcome
Timeframe: week 12Outcome measures
| Measure |
Pioglitazone + Therapy + Contingency Management
n=15 Participants
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
|
Placebo + Therapy + Contingency Management
n=15 Participants
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
|
|---|---|---|
|
Feasibility - Subject Retention as Assessed by Number of Participants Who Completed All 12 Weeks of the Study
|
12 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: weeks 1 - 12Riboflavin 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.
Outcome measures
| Measure |
Pioglitazone + Therapy + Contingency Management
n=12 Participants
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
|
Placebo + Therapy + Contingency Management
n=14 Participants
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
|
|---|---|---|
|
Feasibility - Medication Compliance as Assessed by Percentage of Urine Samples That Were Riboflavin-Positive
|
96.2 percentage of urine samples
Standard Error 0.055194
|
95.4 percentage of urine samples
Standard Error 0.055987
|
SECONDARY outcome
Timeframe: weeks 1 - 12A 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.
Outcome measures
| Measure |
Pioglitazone + Therapy + Contingency Management
n=12 Participants
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
|
Placebo + Therapy + Contingency Management
n=14 Participants
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
|
|---|---|---|
|
Feasibility - Medication Compliance as Assessed by Percentage of Self-reports That Indicate Capsules Were Taken
|
84.1 percentage of self-reports
Standard Error 0.105562
|
86.9 percentage of self-reports
Standard Error 0.090174
|
SECONDARY outcome
Timeframe: week 12Outcome measures
| Measure |
Pioglitazone + Therapy + Contingency Management
n=12 Participants
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
|
Placebo + Therapy + Contingency Management
n=14 Participants
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
|
|---|---|---|
|
Feasibility - Tolerability as Assessed by Number of Participants Reporting Side Effects
increased urination
|
4 Participants
|
1 Participants
|
|
Feasibility - Tolerability as Assessed by Number of Participants Reporting Side Effects
drowsiness
|
0 Participants
|
1 Participants
|
|
Feasibility - Tolerability as Assessed by Number of Participants Reporting Side Effects
not sleeping well
|
2 Participants
|
1 Participants
|
|
Feasibility - Tolerability as Assessed by Number of Participants Reporting Side Effects
headache
|
0 Participants
|
1 Participants
|
|
Feasibility - Tolerability as Assessed by Number of Participants Reporting Side Effects
nervousness
|
0 Participants
|
2 Participants
|
|
Feasibility - Tolerability as Assessed by Number of Participants Reporting Side Effects
blurry vision
|
0 Participants
|
2 Participants
|
|
Feasibility - Tolerability as Assessed by Number of Participants Reporting Side Effects
dizziness
|
0 Participants
|
1 Participants
|
|
Feasibility - Tolerability as Assessed by Number of Participants Reporting Side Effects
nausea
|
0 Participants
|
1 Participants
|
|
Feasibility - Tolerability as Assessed by Number of Participants Reporting Side Effects
vomiting
|
1 Participants
|
1 Participants
|
|
Feasibility - Tolerability as Assessed by Number of Participants Reporting Side Effects
diarrhea
|
2 Participants
|
1 Participants
|
|
Feasibility - Tolerability as Assessed by Number of Participants Reporting Side Effects
stomach pain
|
3 Participants
|
2 Participants
|
|
Feasibility - Tolerability as Assessed by Number of Participants Reporting Side Effects
muscle aches
|
0 Participants
|
1 Participants
|
|
Feasibility - Tolerability as Assessed by Number of Participants Reporting Side Effects
shortness of breath
|
0 Participants
|
1 Participants
|
|
Feasibility - Tolerability as Assessed by Number of Participants Reporting Side Effects
cough
|
4 Participants
|
1 Participants
|
|
Feasibility - Tolerability as Assessed by Number of Participants Reporting Side Effects
change in sexual function
|
1 Participants
|
1 Participants
|
|
Feasibility - Tolerability as Assessed by Number of Participants Reporting Side Effects
weakness
|
0 Participants
|
1 Participants
|
|
Feasibility - Tolerability as Assessed by Number of Participants Reporting Side Effects
fatigue
|
1 Participants
|
0 Participants
|
|
Feasibility - Tolerability as Assessed by Number of Participants Reporting Side Effects
difficulty walking
|
1 Participants
|
0 Participants
|
|
Feasibility - Tolerability as Assessed by Number of Participants Reporting Side Effects
fever or chills
|
0 Participants
|
2 Participants
|
|
Feasibility - Tolerability as Assessed by Number of Participants Reporting Side Effects
loss of appetite
|
0 Participants
|
1 Participants
|
|
Feasibility - Tolerability as Assessed by Number of Participants Reporting Side Effects
confusion
|
0 Participants
|
1 Participants
|
|
Feasibility - Tolerability as Assessed by Number of Participants Reporting Side Effects
cloudiness
|
0 Participants
|
1 Participants
|
|
Feasibility - Tolerability as Assessed by Number of Participants Reporting Side Effects
memory loss
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: week 12Outcome measures
| Measure |
Pioglitazone + Therapy + Contingency Management
n=12 Participants
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
|
Placebo + Therapy + Contingency Management
n=14 Participants
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
|
|---|---|---|
|
Feasibility - Tolerability as Assessed by Number of Participants With Serious Adverse Events
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Weeks 1-12The mean percentage over all time points is reported in this outcome measure. Urine samples were collected once weekly.
Outcome measures
| Measure |
Pioglitazone + Therapy + Contingency Management
n=12 Participants
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
|
Placebo + Therapy + Contingency Management
n=14 Participants
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
|
|---|---|---|
|
Cocaine Use as Assessed by Percentage of Urine Samples That Were Cocaine-positive
|
44 percentage of urine samples
Standard Deviation 0.34
|
50 percentage of urine samples
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Weeks 1-12A 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.
Outcome measures
| Measure |
Pioglitazone + Therapy + Contingency Management
n=12 Participants
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
|
Placebo + Therapy + Contingency Management
n=14 Participants
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
|
|---|---|---|
|
Cocaine Use as Assessed by Percentage of Self-reports That Indicate Cocaine Use
|
35 percentage of self-reports
Standard Deviation 0.3
|
29 percentage of self-reports
Standard Deviation 0.28
|
Adverse Events
Pioglitazone + Therapy + Contingency Management
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo + Therapy + Contingency Management
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Joy M. Schmitz, PhD
The University of Texas Health Science Center at Houston
Phone: 713-486-2867
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place