Cocaine Use DisorderPhase 1/2NCT02774343

PPARγ Agonist Treatment for Cocaine Dependence

A Phase 1/2 study testing Pioglitazone, Therapy and Contingency Management in people with Cocaine Use Disorder and Alcohol Use Disorder, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Cocaine Use Disorder, Alcohol Use Disorder
What is being tested?: Pioglitazone, Therapy and Contingency Management
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteUnited States
Study dates: Aug 2012to Jun 2015
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

DSM-IV criteria for cocaine dependence
At least one cocaine positive urine during screening
Female subjects: a negative pregnancy test
Be in acceptable health on the basis of interview, medical history and physical exam
Be able to understand the consent form and provide written informed consent
Be able to provide the names of at least 2 persons who can generally locate their whereabouts.

Who cannot join

Current Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV diagnosis of any psychoactive substance dependence other than cocaine marijuana, alcohol, or nicotine
Any serious medical or psychiatric illness and/or clinically significant abnormal laboratory value, which in the judgment of the Principal Investigator or his/her designee would make study participation unsafe, or would make treatment compliance difficult or put the study staff at undue risk
Significant current suicidal or homicidal ideation
Medical conditions contraindicating pioglitazone pharmacotherapy (e.g., congestive heart failure as determined by Framingham criteria, clinically significant edema, clinically significant liver disease, hypoglycemia, diabetes, history of bladder cancer)
Taking medications known to have significant drug interactions with the study medication (CYP2C8 inhibitors or inducers, antihyperglycemic medications)
Currently being treated for substance misuse with medication

Show all 14Show fewer

Conditions of probation or parole requiring reports of drug use to officers of the court
Impending incarceration
Pregnant or planning to become pregnant during the course of the trial or nursing for female patients
Inability to read, write, or speak English (many of the research instruments in this study only exist in English)
Having plans to leave the immediate geographical area within 3 months
Unwillingness to sign a written informed consent form
Unwillingness to use a barrier method of birth control during the study for female patients
History of pacemaker or metal implants or welding or metal work without protective eyewear (for risk of MRI scans).

Trial locations and contacts

1 site in 1 country.

United States1 site

The University of Texas Health Science Center at Houston
Houston, Texas, 77030

Other trials in United States

About this study

Conditions: Cocaine Use Disorder, Alcohol Use Disorder
Being tested: Pioglitazone, Placebo, Therapy, Contingency Management
Medical subject headings: Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PioglitazoneDrug
Also called Actos
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.
PlaceboDrug
Also called corn starch
Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.
TherapyBehavioural
Cognitive-behavioral therapy 1 hour per week
Contingency ManagementBehavioural
Prize-based contingency management for attendance

Study groups in NCT02774343
Study group	Role	What they receive
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. Receives: Drug: Pioglitazone; Behavioral: Therapy; Behavioral: Contingency Management
Placebo + Therapy + Contingency Management	Placebo comparator	Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study. Receives: Drug: Placebo; Behavioral: Therapy; Behavioral: Contingency Management

What is being measured

The primary outcome is the main question the study is designed to answer.

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.)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 12

Secondary outcomes (7)

Feasibility - Subject Retention as Assessed by Number of Participants Who Completed All 12 Weeks of the Study
Measured: 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.
Measured: 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.
Measured: weeks 1 - 12
Feasibility - Tolerability as Assessed by Number of Participants Reporting Side Effects
Measured: week 12
Feasibility - Tolerability as Assessed by Number of Participants With Serious Adverse Events
Measured: 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.
Measured: 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.
Measured: Weeks 1-12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2012Jun 2015

First posted17 May 2016 (estimated)
Study startAug 2012
Primary completionJun 2015
Study completionJun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cocaine Use DisorderStudies of the same condition, open and under way.
More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02774343
Sponsor's protocol ID: HSC-MS-12-0421
Other IDs: P50DA009262
Status last verified: Mar 2018
First submitted: 6 May 2016
Last updated: 26 Apr 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder
Cocaine Use, Cocaine Dependence
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Active, not recruitingPhase 2
An Open-Label Tirzepatide Trial for Comorbid Obesity and Stimulant Use Disorder
Obesity, Methamphetamine Use Disorder
Recruiting
Transcranial Direct Current Stimulation (tDCS) for Treatment of Substance Use Disorder
Cocaine Use Disorder, Cocaine Dependence
Not yet recruiting
Examination of Transcranial Focused Ultrasound on Brain Activity in Adults With Cocaine Use Disorder
Cocaine Use Disorder (CUD)

All Cocaine Use Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PPARγ Agonist Treatment for Cocaine Dependence
ClinicalTrials.gov ID: NCT02774343
Acronym / sponsor ID: HSC-MS-12-0421
Conditions: Cocaine Use Disorder, Alcohol Use Disorder
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: Aug 2012
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 17 May 2016 (estimated)
Results: Posted 26 Apr 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Pioglitazone + Therapy + Contingency Management	Experimental	Drug: Pioglitazone, Behavioral: Therapy, Behavioral: Contingency ManagementSubjects 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	Drug: Placebo, Behavioral: Therapy, Behavioral: Contingency ManagementSubjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

DSM-IV criteria for cocaine dependence
At least one cocaine positive urine during screening
Female subjects: a negative pregnancy test
Be in acceptable health on the basis of interview, medical history and physical exam
Be able to understand the consent form and provide written informed consent

Key exclusion criteria (14 listed)

Current Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV diagnosis of any psychoactive substance dependence other than cocaine marijuana, alcohol, or nicotine
Any serious medical or psychiatric illness and/or clinically significant abnormal laboratory value, which in the judgment of the Principal Investigator or his/her designee would make study participation unsafe, or would make treatment compliance difficult or put the study staff at undue risk
Significant current suicidal or homicidal ideation
Medical conditions contraindicating pioglitazone pharmacotherapy (e.g., congestive heart failure as determined by Framingham criteria, clinically significant edema, clinically significant liver disease, hypoglycemia, diabetes, history of bladder cancer)
Taking medications known to have significant drug interactions with the study medication (CYP2C8 inhibitors or inducers, antihyperglycemic medications)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PioglitazoneAlso: ActosSubjects 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.	Drug	Pioglitazone + Therapy + Contingency Management
PlaceboAlso: corn starchSubjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.	Drug	Placebo + Therapy + Contingency Management
TherapyCognitive-behavioral therapy 1 hour per week	Behavioural	Pioglitazone + Therapy + Contingency Management, Placebo + Therapy + Contingency Management
Contingency ManagementPrize-based contingency management for attendance	Behavioural	Pioglitazone + Therapy + Contingency Management, Placebo + Therapy + Contingency Management

Primary outcome

Craving as Assessed by the Brief Substance Craving Scale (BSCS)
Time frame: 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
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.)
Craving as Assessed by the Obsessive Compulsive Drug Use Scale (OCDUS)
Time frame: Weeks 1-12
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.
Cue Reactivity as Assessed by a Visual Analogue Scale (VAS) of Cocaine Craving
Time frame: Baseline, week 2, week 4, week 6, week 8, week 10, week 12
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.
Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Posterior Thalamic Radiation)
Time frame: Baseline and Week 12
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.
Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Anterior Thalamic Radiation)
Time frame: Baseline and Week 12
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.
Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Splenium of Corpus Callosum)
Time frame: Baseline and Week 12
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.
Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Genu of Corpus Callosum)
Time frame: Baseline and Week 12
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.
Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - External Capsule)
Time frame: Baseline and Week 12
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.
Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Cingulum)
Time frame: Baseline and Week 12
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.

7 secondary outcomes

Feasibility - Subject Retention as Assessed by Number of Participants Who Completed All 12 Weeks of the Study
Time frame: week 12
Feasibility - Medication Compliance as Assessed by Percentage of Urine Samples That Were Riboflavin-Positive
Time frame: weeks 1 - 12
Feasibility - Medication Compliance as Assessed by Percentage of Self-reports That Indicate Capsules Were Taken
Time frame: weeks 1 - 12
Feasibility - Tolerability as Assessed by Number of Participants Reporting Side Effects
Time frame: week 12
Feasibility - Tolerability as Assessed by Number of Participants With Serious Adverse Events
Time frame: week 12
Cocaine Use as Assessed by Percentage of Urine Samples That Were Cocaine-positive
Time frame: Weeks 1-12
Cocaine Use as Assessed by Percentage of Self-reports That Indicate Cocaine Use
Time frame: Weeks 1-12

Results and safety

Results posted to the registry on 26 Apr 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pioglitazone + Therapy + Contingency Management	15	9
Placebo + Therapy + Contingency Management	15	12

Primary outcome: Craving as Assessed by the Brief Substance Craving Scale (BSCS)

Time frame: 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. Mean (Standard Deviation). Unit: units on a scale

Measure	Pioglitazone + Therapy + Contingency Management n = 12	Placebo + Therapy + Contingency Management n = 14
baseline	5.57 (2.47)	6.23 (3.30)
week 1	5.00 (3.36)	5.08 (3.06)
week 2	4.42 (2.11)	2.91 (2.55)
week 3	4.00 (3.33)	3.82 (3.89)
week 4	4.00 (3.16)	3.18 (2.75)
week 5	2.60 (2.55)	3.82 (2.79)
week 6	3.22 (2.78)	3.45 (3.39)
week 7	2.12 (1.64)	4.36 (3.14)

Primary outcome: Craving as Assessed by the Obsessive Compulsive Drug Use Scale (OCDUS)

Time frame: Weeks 1-12. Mean (Standard Deviation). Unit: units on a scale

Measure	Pioglitazone + Therapy + Contingency Management n = 12	Placebo + Therapy + Contingency Management n = 14
Value	19.1 (3.5)	21.36 (8.7)

Primary outcome: Cue Reactivity as Assessed by a Visual Analogue Scale (VAS) of Cocaine Craving

Time frame: Baseline, week 2, week 4, week 6, week 8, week 10, week 12. Mean (Standard Deviation). Unit: units on a scale

Measure	Pioglitazone + Therapy + Contingency Management n = 12	Placebo + Therapy + Contingency Management n = 14
baseline	57.50 (22.83)	52.29 (29.49)
week 2	53.76 (23.10)	40.31 (29.38)
week 4	37.93 (22.30)	35.58 (29.00)
week 6	21.75 (22.97)	29.86 (31.27)
week 8	25.70 (23.34)	35.88 (34.20)
week 10	18.33 (24.38)	31.42 (35.61)
week 12	15.38 (28.91)	27.86 (30.20)

Primary outcome: Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Posterior Thalamic Radiation)

Time frame: Baseline and Week 12. Mean (Standard Deviation). Unit: DTI Fractional Anisotropy (FA) value

Measure	Pioglitazone + Therapy + Contingency Management n = 8	Placebo + Therapy + Contingency Management n = 10
baseline	542.27 (24.60)	546.26 (27.02)
week 12	546.84 (32.79)	535.14 (27.61)

Population analysed: 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.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pioglitazone + Therapy + Contingency Management	0 of 12 (0%)	0 of 12 (0%)	Not reported
Placebo + Therapy + Contingency Management	0 of 14 (0%)	0 of 14 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Cocaine Use Disorder

Recruiting
rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder
Cocaine Use, Cocaine Dependence
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Active, not recruitingPhase 2
An Open-Label Tirzepatide Trial for Comorbid Obesity and Stimulant Use Disorder
Obesity, Methamphetamine Use Disorder
Recruiting
Transcranial Direct Current Stimulation (tDCS) for Treatment of Substance Use Disorder
Cocaine Use Disorder, Cocaine Dependence
Not yet recruiting
Examination of Transcranial Focused Ultrasound on Brain Activity in Adults With Cocaine Use Disorder
Cocaine Use Disorder (CUD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joy M Schmitz, PhD principal investigator

The University of Texas Health Science Center, Houston

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Craving as Assessed by the Brief Substance Craving Scale (BSCS) (time frame: 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). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02774343.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2018; AzTrials last refreshed its copy on 3 Nov 2026.