Trial Outcomes & Findings for Effects of Pioglitazone on Stress Reactivity and Alcohol Craving (Pilot) (NCT NCT03860753)
NCT ID: NCT03860753
Last Updated: 2020-10-26
Results Overview
The cold pressor task (CPT) a stress-inducer in human laboratory studies that elicits moderate activation of the sympathetic nervous system and limited activation of the HPA-axis. During CPT, participants will submerge their dominant arm in an ice-water bath for up to 2 minutes, and heart rate will be measured before and after CPT. The heart rate change for each time point is calculated as heart rate after CPT minus the heart rate before CPT. This outcome measure reports the heart rate change at week 4 minus the heart rate change at baseline.
TERMINATED
PHASE1/PHASE2
4 participants
baseline, week 4
2020-10-26
Participant Flow
Participant milestones
| Measure |
Pioglitazone
Pioglitazone: For the current trial we will follow recommended adult initial dosing at 30 mg/d to reach maintenance dose of 45 mg/d by week 2, which is within standard titration parameters as per the investigator's brochure.
|
Placebo
Placebo: Pill capsules will look same as that of active drug.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
0
|
|
Overall Study
COMPLETED
|
4
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Pioglitazone on Stress Reactivity and Alcohol Craving (Pilot)
Baseline characteristics by cohort
| Measure |
Pioglitazone
n=4 Participants
Pioglitazone: For the current trial we will follow recommended adult initial dosing at 30 mg/d to reach maintenance dose of 45 mg/d by week 2, which is within standard titration parameters as per the investigator's brochure.
|
Placebo
Placebo: Pill capsules will look same as that of active drug.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.5 years
STANDARD_DEVIATION 5.20 • n=5 Participants
|
—
|
30.5 years
STANDARD_DEVIATION 5.20 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, week 4Population: All 4 participants were allocated to Pioglitazone and none to placebo.
The cold pressor task (CPT) a stress-inducer in human laboratory studies that elicits moderate activation of the sympathetic nervous system and limited activation of the HPA-axis. During CPT, participants will submerge their dominant arm in an ice-water bath for up to 2 minutes, and heart rate will be measured before and after CPT. The heart rate change for each time point is calculated as heart rate after CPT minus the heart rate before CPT. This outcome measure reports the heart rate change at week 4 minus the heart rate change at baseline.
Outcome measures
| Measure |
Pioglitazone
n=4 Participants
Pioglitazone: For the current trial we will follow recommended adult initial dosing at 30 mg/d to reach maintenance dose of 45 mg/d by week 2, which is within standard titration parameters as per the investigator's brochure.
|
Placebo
Placebo: Pill capsules will look same as that of active drug.
|
|---|---|---|
|
Change in Stress-reactivity as Assessed by Heart Rate Change During the Cold Pressor Task (CPT)
|
-4.67 beats per minute
Standard Deviation 11.60
|
—
|
PRIMARY outcome
Timeframe: baseline, week 4Population: All 4 participants were allocated to Pioglitazone and none to placebo.
The cold pressor task (CPT) a stress-inducer in human laboratory studies that elicits moderate activation of the sympathetic nervous system and limited activation of the HPA-axis. During CPT, participants will submerge their dominant arm in an ice-water bath for up to 2 minutes, and blood pressure will be measured before and after CPT. The blood pressure change for each time point is calculated as blood pressure after CPT minus the blood pressure before CPT. This outcome measure reports the blood pressure change at week 4 minus the blood pressure change at baseline.
Outcome measures
| Measure |
Pioglitazone
n=4 Participants
Pioglitazone: For the current trial we will follow recommended adult initial dosing at 30 mg/d to reach maintenance dose of 45 mg/d by week 2, which is within standard titration parameters as per the investigator's brochure.
|
Placebo
Placebo: Pill capsules will look same as that of active drug.
|
|---|---|---|
|
Change in Stress-reactivity as Assessed by Change in Systolic Blood Pressure During the Cold Pressor Task (CPT)
|
-2.67 millimeters of mercury (mmHg)
Standard Deviation 0.58
|
—
|
PRIMARY outcome
Timeframe: baseline, week 4Population: All 4 participants were allocated to Pioglitazone and none to placebo.
The cold pressor task (CPT) a stress-inducer in human laboratory studies that elicits moderate activation of the sympathetic nervous system and limited activation of the HPA-axis. During CPT, participants will submerge their dominant arm in an ice-water bath for up to 2 minutes, and blood pressure will be measured before and after CPT. The blood pressure change for each time point is calculated as blood pressure after CPT minus the blood pressure before CPT. This outcome measure reports the blood pressure change at week 4 minus the blood pressure change at baseline.
Outcome measures
| Measure |
Pioglitazone
n=4 Participants
Pioglitazone: For the current trial we will follow recommended adult initial dosing at 30 mg/d to reach maintenance dose of 45 mg/d by week 2, which is within standard titration parameters as per the investigator's brochure.
|
Placebo
Placebo: Pill capsules will look same as that of active drug.
|
|---|---|---|
|
Change in Stress-reactivity as Assessed by Diastolic Blood Pressure Change During the Cold Pressor Task (CPT)
|
-7.67 millimeters of mercury (mmHg)
Standard Deviation 8.08
|
—
|
PRIMARY outcome
Timeframe: baseline, week 4Population: All 4 participants were allocated to Pioglitazone and none to placebo.
The cold pressor task (CPT) a stress-inducer in human laboratory studies that elicits moderate activation of the sympathetic nervous system and limited activation of the HPA-axis. During CPT, participants will submerge their dominant arm in an ice-water bath for up to 2 minutes, and salivary cortisol level will be measured before and after CPT. The salivary cortisol level change for each time point is calculated as salivary cortisol level after CPT minus the salivary cortisol level before CPT. This outcome measure reports the salivary cortisol level change at week 4 minus the salivary cortisol level change at baseline.
Outcome measures
| Measure |
Pioglitazone
n=4 Participants
Pioglitazone: For the current trial we will follow recommended adult initial dosing at 30 mg/d to reach maintenance dose of 45 mg/d by week 2, which is within standard titration parameters as per the investigator's brochure.
|
Placebo
Placebo: Pill capsules will look same as that of active drug.
|
|---|---|---|
|
Change in Stress-reactivity as Assessed by Salivary Cortisol Level Change During the Cold Pressor Task (CPT)
|
-108.07 picograms per milliliter (pg/mL)
Standard Deviation 830.46
|
—
|
PRIMARY outcome
Timeframe: baseline, week 4Population: All 4 participants were allocated to Pioglitazone and none to placebo.
The visual analogue scale (VAS) ranges from 0-10, with a higher score indicating higher stress.
Outcome measures
| Measure |
Pioglitazone
n=4 Participants
Pioglitazone: For the current trial we will follow recommended adult initial dosing at 30 mg/d to reach maintenance dose of 45 mg/d by week 2, which is within standard titration parameters as per the investigator's brochure.
|
Placebo
Placebo: Pill capsules will look same as that of active drug.
|
|---|---|---|
|
Change in Stress-reactivity as Assessed by Self-report on a Visual Analogue Scale (VAS)
|
-1.33 units on a scale
Standard Deviation 1.53
|
—
|
SECONDARY outcome
Timeframe: baseline, week 4Population: All 4 participants were allocated to Pioglitazone and none to placebo.
The Alcohol Timeline Followback (TLFB) is a drinking assessment method that obtains an estimate of daily drinking. Participants provide a retrospective estimate of the number of drinks per week for the last seven days.
Outcome measures
| Measure |
Pioglitazone
n=4 Participants
Pioglitazone: For the current trial we will follow recommended adult initial dosing at 30 mg/d to reach maintenance dose of 45 mg/d by week 2, which is within standard titration parameters as per the investigator's brochure.
|
Placebo
Placebo: Pill capsules will look same as that of active drug.
|
|---|---|---|
|
Change in Alcohol Use as Indicated by Self Report Using the Alcohol Timeline Followback (TLFB)
|
-13.38 number of drinks per week
Standard Deviation 11.22
|
—
|
SECONDARY outcome
Timeframe: baseline, week 4Population: All 4 participants were allocated to Pioglitazone and none to placebo.
The Penn Alcohol Craving Scale (PACS) is a 5-item questionnaire that measures an individual's craving to drink alcohol in the past week. Each item is scored on a scale from 0 to 6, with a total score range of 0 to 30. A higher score indicates greater level of alcohol craving.
Outcome measures
| Measure |
Pioglitazone
n=4 Participants
Pioglitazone: For the current trial we will follow recommended adult initial dosing at 30 mg/d to reach maintenance dose of 45 mg/d by week 2, which is within standard titration parameters as per the investigator's brochure.
|
Placebo
Placebo: Pill capsules will look same as that of active drug.
|
|---|---|---|
|
Change in Alcohol Craving as Assessed by Self Report Using the The Penn Alcohol Craving Scale (PACS).
|
-8.5 score on a scale
Standard Deviation 6.6
|
—
|
Adverse Events
Pioglitazone
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pioglitazone
n=4 participants at risk
Pioglitazone: For the current trial we will follow recommended adult initial dosing at 30 mg/d to reach maintenance dose of 45 mg/d by week 2, which is within standard titration parameters as per the investigator's brochure.
|
Placebo
Placebo: Pill capsules will look same as that of active drug.
|
|---|---|---|
|
General disorders
weight gain
|
50.0%
2/4 • Number of events 2 • 4 weeks
All 4 participants were allocated to Pioglitazone and none to placebo.
|
—
0/0 • 4 weeks
All 4 participants were allocated to Pioglitazone and none to placebo.
|
|
General disorders
right ankle stiffness
|
25.0%
1/4 • Number of events 1 • 4 weeks
All 4 participants were allocated to Pioglitazone and none to placebo.
|
—
0/0 • 4 weeks
All 4 participants were allocated to Pioglitazone and none to placebo.
|
Additional Information
Jin Ho Yoon, PhD
The University of Texas Health Science Center at Houston
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place