Dyssocial BehaviorPhase 4NCT04865562
Hormones and Decision Making
A Phase 4 study testing testosterone propionate and 0.5% cholorbutanol, saline in people with Dyssocial Behavior, run by University of Texas at Austin at 1 site in United States.
Trial summary
An investigation of the neuropsychological processes underlying ethical decision making. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dyssocial Behavior
- What is being tested?
- testosterone propionate and 0.5% cholorbutanol, saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2015to 1 Sep 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- males between 18 and 25
Who cannot join
- recruitment will be limited to male participants between 18 and 25 years who have no current conditions that would preclude the use of testosterone. Specific exclusion criteria are:
- women of all ages
- males younger than 18 years and older than 25 years
- self-report discomfort with ingestion of testosterone for the purpose of this study
- body mass index lower than 18 or higher than 27
- prior diagnosis of major depression, posttraumatic stress disorder, phobia, anxiety disorder, or other psychiatric conditions
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- first-degree relatives diagnosed with a psychiatric disorder
- presence of a medical condition that would preclude the use of testosterone
- use of medications that would preclude the use of testosterone
- consumption of more than 5 cigarettes a day
- current use of testosterone enhancing products, such as gels, creams, and injections
Trial locations and contacts
1 site in 1 country.
About this study
An investigation of the neuropsychological processes underlying ethical decision making.
Read the detailed description
This study will investigate the influence of reward sensitivity on cheating behavior via experimental manipulation of reward sensitivity using testosterone.
- Conditions
- Dyssocial Behavior
- Being tested
- testosterone propionate, 0.5% cholorbutanol, saline
- Medical subject headings
- Antisocial Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
testosterone propionateDrug
Also called Testovis
1mg/0.1mL solution, to be administered intranasally
0.5% cholorbutanol, salineDrug
125 mg 0.5% cholorbutanol, 50mg saline
| Study group | Role | What they receive |
|---|---|---|
| testosterone | Experimental | 7mg testosterone propionate Receives: Drug: testosterone propionate |
| placebo | Placebo comparator | 125 mg 0.5% cholorbutanol, 50mg saline, pH5 Receives: Drug: 0.5% cholorbutanol, saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of ethical behavior - Cheating rate defined as the Average number of 'heads' coin flips participants claim to have obtained
drug administration following by behavioral outcome. Specifically, participants will have the opportunity to predict the outcome of a series of coin flips. To obtain a measure of ethical behavior, participants will have the opportunity to cheat by over-reporting their prediction accuracy.
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start1 Mar 2015
- Primary completion1 May 2016
- Study completion1 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dyssocial BehaviorStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Josephs, University of Texas at Austin
- Investigators
- Robert A Josephs, PhD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04865562
- Sponsor's protocol ID
- 2015-02-0011
- Status last verified
- Apr 2021
- First submitted
- 9 Feb 2015
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hormones and Decision Making
- ClinicalTrials.gov ID
- NCT04865562
- Acronym / sponsor ID
- 2015-02-0011
- Conditions
- Dyssocial Behavior
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 1 May 2016 (actual)
- Study completion
- 1 Sep 2016 (actual)
- First posted
- 29 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An investigation of the neuropsychological processes underlying ethical decision making.
Detailed description
This study will investigate the influence of reward sensitivity on cheating behavior via experimental manipulation of reward sensitivity using testosterone.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| testosterone | Experimental | Drug: testosterone propionate7mg testosterone propionate |
| placebo | Placebo comparator | Drug: 0.5% cholorbutanol, saline125 mg 0.5% cholorbutanol, 50mg saline, pH5 |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- males between 18 and 25
Key exclusion criteria (11 listed)
- recruitment will be limited to male participants between 18 and 25 years who have no current conditions that would preclude the use of testosterone. Specific exclusion criteria are:
- women of all ages
- males younger than 18 years and older than 25 years
- self-report discomfort with ingestion of testosterone for the purpose of this study
- body mass index lower than 18 or higher than 27
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 |
|---|---|---|
| testosterone propionateAlso: Testovis1mg/0.1mL solution, to be administered intranasally | Drug | testosterone |
| 0.5% cholorbutanol, saline125 mg 0.5% cholorbutanol, 50mg saline | Drug | placebo |
Primary outcome
Measure of ethical behavior - Cheating rate defined as the Average number of 'heads' coin flips participants claim to have obtained
Time frame: 90 minutes
drug administration following by behavioral outcome. Specifically, participants will have the opportunity to predict the outcome of a series of coin flips. To obtain a measure of ethical behavior, participants will have the opportunity to cheat by over-reporting their prediction accuracy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
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.
Robert A Josephs, PhD principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing testosterone propionate and 0.5% cholorbutanol, saline in people with Dyssocial Behavior, run by University of Texas at Austin at 1 site in United States.
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 1 inclusion and 11 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 29 Apr 2021. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measure of ethical behavior - Cheating rate defined as the Average number of 'heads' coin flips participants claim to have obtained (time frame: 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2021.