Cocaine DependenceNCT01573273
Oxytocin in Cocaine Dependence
A study testing Oxytocin and Saline in people with Cocaine Dependence, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Stress is likely involved in relapse to cocaine use. This project will investigate the role oxytocin may play in the stress response in cocaine-dependent men and women and examine how oxytocin may impact brain activity in individuals exposed to cocaine-related cues. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cocaine Dependence
- What is being tested?
- Oxytocin and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to 19 Dec 2017
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
- Subjects must meet DSM-IV criteria for current cocaine dependence (within the past three months). While individuals may also meet criteria for abuse of other substances, they must not meet criteria for dependence on any other substance (except nicotine) within the last 60 days. Alcohol has been known to affect HPA function (Adinoff et al., 1991), however to enhance recruitment efforts individuals with alcohol dependence or abuse will be included in the study if they do not require medically supervised detoxification. Also, due to the high comorbidity of cocaine and marijuana dependence, and limited evidence that marijuana use affects HPA function, subjects with marijuana dependence will be included.
- Subjects must consent to remain abstinent from all drugs of abuse (except nicotine) for a three-day period immediately prior to the throughout study procedures.
- Subjects must consent to random assignment.
- Subjects must consent to participating in study procedures at the ASD and completion of two fMRI scans.
Who cannot join
- Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control (not including hormonal contraceptives).
- Women who are currently taking, or have taken in the past month, oral or other types of hormonal contraceptives or hormone replacement therapies.
- Women with premenstrual dysphoric disorder who are outside of the follicular phase.
- Women who have had a complete hysterectomy or are over 50 over one year post-menopausal, as ovarian hormones will be measured in the study.
- Subjects with evidence of or a history of significant hematological, endocrine, cardiovascular, pulmonary, renal, gastrointestinal, or neurological disease including diabetes, as these conditions may affect physiological/subjective responses. Neurological exclusions include history of stroke, seizure disorders, multiple sclerosis, Parkinson's disease, and Alzheimer's disease.
- Subjects with Addison's disease, Cushing's disease or other diseases of the adrenal cortex likely to affect hormonal/neuroendocrine status.
Show all 18Show fewer
- Subjects with a history of or current psychotic disorder or bipolar affective disorder as these may interfere with subjective measurements.
- Subjects with current major depressive disorder or post-traumatic stress disorder as these disorders are associated with characteristic changes in stress response.
- Subjects receiving synthetic glucocorticoid therapy, any exogenous steroid therapy, or treatment with other agents that interfere with hormonal measurements within one month of test session.
- Subjects taking any mood stabilizers, antipsychotics, benzodiazepines, opiates or opiate antagonists because these may affect test response. Subjects taking SSRI's will be included.
- Subjects with any acute illness or fever. Individuals who otherwise meet study criteria will be rescheduled for evaluation for participation.
- Subjects whose height to weight ratio would preclude them from fitting comfortably in the MRI scanner.
- Subjects who are unwilling or unable to maintain abstinence from alcohol and other drugs of abuse (except nicotine) for three days prior to the stress task procedure.
- Persons with ferrous metal implants or pacemaker since fMRI will be used.
- Subjects who are claustrophobic.
- Subjects with significant psychiatric or medical problems that would impair participation or limit ability to participate in scan.
- Subjects who require maintenance or acute treatment with any psychoactive medication including anti-seizure medications which could potentially interfere with fMRI.
- Subjects meeting DSM-IV criteria for substance dependence (other than nicotine, cocaine, alcohol or marijuana) within the past 60 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Stress is likely involved in relapse to cocaine use. This project will investigate the role oxytocin may play in the stress response in cocaine-dependent men and women and examine how oxytocin may impact brain activity in individuals exposed to cocaine-related cues.
Read the detailed description
Stress is an important predictor of relapse, and targeting stress-activated pathways may lead to therapeutic advancements in the treatment of substance use disorders. Oxytocin has been shown to promote trust, social bonding, and calmness; however, its potential effects have not been explored in cocaine-dependent individuals. Oxytocin receptors have been localized to brain regions that are activated by drug-paired cues and preclinical studies have shown that oxytocin attenuates the acute and long-term behavioral effects of psychostimulants. However, little is known about the role of oxytocin in mediating the affective response to cocaine-paired cues and associated neural activity in cocaine-dependent men and women. This project is a direct evolution from our previous SCOR-supported research. Our work has progressed from characterizing sex/gender differences in response to social stressors and cocaine cues in cocaine-dependent men and women, to our on-going work evaluating whether stress potentiates cue-induced craving and the impact of hormones on this response. The proposed study will investigate the role of oxytocin in the sex/gender differences in stress response and craving in cocaine-dependent individuals and preliminarily explore its therapeutic potential.
- Conditions
- Cocaine Dependence
- Being tested
- Oxytocin, Saline
- Keywords
- cocaine, substance abuse, drug abuse, cocaine dependence, drug addiction
- Medical subject headings
- Cocaine-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called pitocin
intranasal administration, 40 IUs
SalineDrug
Also called pitocin
intranasal administration, 40 IUs
| Study group | Role | What they receive |
|---|---|---|
| TSST Women Oxytocin | Experimental | Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task. Receives: Drug: Oxytocin |
| TSST Women Placebo | Placebo comparator | Cocaine-dependent women received intranasal saline prior to completing a Social Stress Task. Receives: Drug: Saline |
| MRI 1 Women Oxytocin | Experimental | Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing the first of two fMRI cue-exposure tasks. Receives: Drug: Oxytocin |
| MRI 1 Women Placebo | Placebo comparator | Cocaine-dependent women received intranasal saline prior to completing the first of two fMRI cue-exposure tasks. Receives: Drug: Saline |
| MRI 2 Women Oxytocin | Experimental | Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing the second of two fMRI cue-exposure tasks. Receives: Drug: Oxytocin |
| MRI 2 Women Placebo | Placebo comparator | Cocaine-dependent women received intranasal saline prior to completing the second of two fMRI cue-exposure tasks. Receives: Drug: Saline |
| TSST Men Oxytocin | Experimental | Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task. Receives: Drug: Oxytocin |
| TSST Men Placebo | Placebo comparator | Cocaine-dependent men received intranasal saline prior to completing a Social Stress Task. Receives: Drug: Saline |
| MRI I Men Oxytocin | Experimental | Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing the first of two fMRI cue-exposure tasks. Receives: Drug: Oxytocin |
| MRI I Men Placebo | Placebo comparator | Cocaine-dependent men received intranasal saline prior to completing the first of two fMRI cue-exposure tasks. Receives: Drug: Saline |
| MRI 2 Men Oxytocin | Experimental | Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing the second of two fMRI cue-exposure tasks. Receives: Drug: Oxytocin |
| MRI 2 Men Placebo | Placebo comparator | Cocaine-dependent men received intranasal saline prior to completing the second of two fMRI cue-exposure tasks. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Stress Response TSST
Subjects rated stress levels on a 0-10 Likert Scale where 0 is Not at All and 10 is Extremely so that lower scores indicate lower stress levels.
Measured: Subjects rated stress immediately following a Social Stress task on Day 1 of 3.
Subjective Stress Response MRI 1
Subjects rated stress levels on a 0-10 Likert Scale where 0 is Not at All and 10 is Extremely so that lower scores indicate lower stress levels
Measured: Subjects rated Stress immediately following the first of two MRI scans on Day 2 of 3.
Subjective Stress Response MRI 2
Subjects rated stress levels on a 0-10 Likert Scale where 0 is Not at All and 10 is Extremely so that lower scores indicate lower stress levels.
Measured: Subjects rated stress immediately following the second of two MRI scans on Day 3 of 3.
Secondary outcomes (3)
Subject Cocaine Craving TSST
Subjects rated craving on a 0-10 Likert Scale where 0 is Not at All and 10 is Extremely so that lower scores indicate lower craving.
Measured: Subjects rated craving immediately following a Social Stress task on Day 1 of 3.
Subject Cocaine Craving MRI 1
Subjects rated craving on a 0-10 Likert Scale where 0 is Not at All and 10 is Extremely so that lower scores indicate lower craving.
Measured: Subjects rated craving immediately following the first of two MRI scans on Day 2 of 3.
Subject Cocaine Craving MRI 2
Subjects rated craving on a 0-10 Likert Scale where 0 is Not at All and 10 is Extremely so that lower scores indicate lower craving.
Measured: Subjects rated craving immediately following the second of two MRI scans on Day 3 of 3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2012 (estimated)
- Study startOct 2012
- Primary completion19 Dec 2017
- Study completion19 Dec 2017
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 DependenceStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aimee McRae-Clark, Medical University of South Carolina
- Investigators
- Aimee McRae-Clark, Pharm.D., Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01573273
- Sponsor's protocol ID
- 00016890
- Status last verified
- Mar 2019
- First submitted
- 5 Apr 2012
- Last updated
- 13 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxytocin in Cocaine Dependence
- ClinicalTrials.gov ID
- NCT01573273
- Acronym / sponsor ID
- 00016890
- Conditions
- Cocaine Dependence
- Keywords
- cocaine, substance abuse, drug abuse, cocaine dependence, drug addiction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- 19 Dec 2017 (actual)
- Study completion
- 19 Dec 2017 (actual)
- First posted
- 9 Apr 2012 (estimated)
- Results
- Posted 13 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stress is likely involved in relapse to cocaine use. This project will investigate the role oxytocin may play in the stress response in cocaine-dependent men and women and examine how oxytocin may impact brain activity in individuals exposed to cocaine-related cues.
Detailed description
Stress is an important predictor of relapse, and targeting stress-activated pathways may lead to therapeutic advancements in the treatment of substance use disorders. Oxytocin has been shown to promote trust, social bonding, and calmness; however, its potential effects have not been explored in cocaine-dependent individuals. Oxytocin receptors have been localized to brain regions that are activated by drug-paired cues and preclinical studies have shown that oxytocin attenuates the acute and long-term behavioral effects of psychostimulants. However, little is known about the role of oxytocin in mediating the affective response to cocaine-paired cues and associated neural activity in cocaine-dependent men and women. This project is a direct evolution from our previous SCOR-supported research. Our work has progressed from characterizing sex/gender differences in response to social stressors and cocaine cues in cocaine-dependent men and women, to our on-going work evaluating whether stress potentiates cue-induced craving and the impact of hormones on this response. The proposed study will investigate the role of oxytocin in the sex/gender differences in stress response and craving in cocaine-dependent individuals and preliminarily explore its therapeutic potential.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| TSST Women Oxytocin | Experimental | Drug: OxytocinCocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task. |
| TSST Women Placebo | Placebo comparator | Drug: SalineCocaine-dependent women received intranasal saline prior to completing a Social Stress Task. |
| MRI 1 Women Oxytocin | Experimental | Drug: OxytocinCocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing the first of two fMRI cue-exposure tasks. |
| MRI 1 Women Placebo | Placebo comparator | Drug: SalineCocaine-dependent women received intranasal saline prior to completing the first of two fMRI cue-exposure tasks. |
| MRI 2 Women Oxytocin | Experimental | Drug: OxytocinCocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing the second of two fMRI cue-exposure tasks. |
| MRI 2 Women Placebo | Placebo comparator | Drug: SalineCocaine-dependent women received intranasal saline prior to completing the second of two fMRI cue-exposure tasks. |
| TSST Men Oxytocin | Experimental | Drug: OxytocinCocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task. |
| TSST Men Placebo | Placebo comparator | Drug: SalineCocaine-dependent men received intranasal saline prior to completing a Social Stress Task. |
| MRI I Men Oxytocin | Experimental | Drug: OxytocinCocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing the first of two fMRI cue-exposure tasks. |
| MRI I Men Placebo | Placebo comparator | Drug: SalineCocaine-dependent men received intranasal saline prior to completing the first of two fMRI cue-exposure tasks. |
| MRI 2 Men Oxytocin | Experimental | Drug: OxytocinCocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing the second of two fMRI cue-exposure tasks. |
| MRI 2 Men Placebo | Placebo comparator | Drug: SalineCocaine-dependent men received intranasal saline prior to completing the second of two fMRI cue-exposure tasks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
- Subjects must meet DSM-IV criteria for current cocaine dependence (within the past three months). While individuals may also meet criteria for abuse of other substances, they must not meet criteria for dependence on any other substance (except nicotine) within the last 60 days. Alcohol has been known to affect HPA function (Adinoff et al., 1991), however to enhance recruitment efforts individuals with alcohol dependence or abuse will be included in the study if they do not require medically supervised detoxification. Also, due to the high comorbidity of cocaine and marijuana dependence, and limited evidence that marijuana use affects HPA function, subjects with marijuana dependence will be included.
- Subjects must consent to remain abstinent from all drugs of abuse (except nicotine) for a three-day period immediately prior to the throughout study procedures.
- Subjects must consent to random assignment.
- Subjects must consent to participating in study procedures at the ASD and completion of two fMRI scans.
Key exclusion criteria (18 listed)
- Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control (not including hormonal contraceptives).
- Women who are currently taking, or have taken in the past month, oral or other types of hormonal contraceptives or hormone replacement therapies.
- Women with premenstrual dysphoric disorder who are outside of the follicular phase.
- Women who have had a complete hysterectomy or are over 50 over one year post-menopausal, as ovarian hormones will be measured in the study.
- Subjects with evidence of or a history of significant hematological, endocrine, cardiovascular, pulmonary, renal, gastrointestinal, or neurological disease including diabetes, as these conditions may affect physiological/subjective responses. Neurological exclusions include history of stroke, seizure disorders, multiple sclerosis, Parkinson's disease, and Alzheimer's disease.
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 |
|---|---|---|
| OxytocinAlso: pitocinintranasal administration, 40 IUs | Drug | MRI 1 Women Oxytocin, MRI 2 Men Oxytocin, MRI 2 Women Oxytocin, MRI I Men Oxytocin, TSST Men Oxytocin, TSST Women Oxytocin |
| SalineAlso: pitocinintranasal administration, 40 IUs | Drug | MRI 1 Women Placebo, MRI 2 Men Placebo, MRI 2 Women Placebo, MRI I Men Placebo, TSST Men Placebo, TSST Women Placebo |
Primary outcome
Subjective Stress Response TSST
Time frame: Subjects rated stress immediately following a Social Stress task on Day 1 of 3.
Subjects rated stress levels on a 0-10 Likert Scale where 0 is Not at All and 10 is Extremely so that lower scores indicate lower stress levels.
Subjective Stress Response MRI 1
Time frame: Subjects rated Stress immediately following the first of two MRI scans on Day 2 of 3.
Subjects rated stress levels on a 0-10 Likert Scale where 0 is Not at All and 10 is Extremely so that lower scores indicate lower stress levels
Subjective Stress Response MRI 2
Time frame: Subjects rated stress immediately following the second of two MRI scans on Day 3 of 3.
Subjects rated stress levels on a 0-10 Likert Scale where 0 is Not at All and 10 is Extremely so that lower scores indicate lower stress levels.
3 secondary outcomes
Subject Cocaine Craving TSST
Time frame: Subjects rated craving immediately following a Social Stress task on Day 1 of 3.
Subject Cocaine Craving MRI 1
Time frame: Subjects rated craving immediately following the first of two MRI scans on Day 2 of 3.
Subject Cocaine Craving MRI 2
Time frame: Subjects rated craving immediately following the second of two MRI scans on Day 3 of 3.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Aimee McRae-Clark, Pharm.D. principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin and Saline in people with Cocaine Dependence, run by Medical University of South Carolina 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 5 inclusion and 18 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 13 Mar 2019. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2019). 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?
Subjective Stress Response TSST (time frame: Subjects rated stress immediately following a Social Stress task on Day 1 of 3.). The study lists 3 primary outcomes in all. 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 13 Mar 2019.