Cocaine Related DisordersPhase 2NCT00535002
The Effect of Yohimbine on Cocaine Cue Reactivity
A Phase 2 study testing Yohimbine in people with Cocaine Related Disorders, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Stress and cues reminiscent of cocaine use promote craving and relapse in cocaine dependent individuals. In addition, there appears to be gender differences in determinants of relapse to drug use following abstinence in cocaine-dependent individuals. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cocaine Related Disorders
- What is being tested?
- Yohimbine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Aug 2012
- Phase
- Phase 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 65 years
- All sexes
- Healthy volunteers accepted
- 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 consent to remain abstinent from all drugs of abuse (except nicotine) for a three-day period immediately prior to the CTRC admission. Nicotine dependence can affect HPA function (Baron et al., 1995) therefore it would be ideal to exclude subjects with nicotine use. Because of the high comorbidity of cocaine and nicotine dependence, this would seriously compromise the feasibility of recruitment. Individuals with alcohol dependence will be excluded. However because of the high comorbidity of alcohol use and cocaine dependence, individuals with alcohol abuse will be included. 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 with ADHD will be included. Because ADHD is commonly characterized by impulsivity, ADHD severity ratings will be determined and controlled for in data analysis.
- Subjects must consent to random assignment.
- Subjects must consent to outpatient admission to the CTRC and two overnight admissions to the Medical University Hospital.
Who cannot join
- Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control.
- Women with premenstrual dysphoric disorder as this may impact on the response to the stress test procedure (Woods et al., 1994).
- Women receiving depot medroxyprogesterone acetate as a form of birth control.
- 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.
- Subjects with Addison's disease, Cushing's disease or other diseases of the adrenal cortex likely to affect hormonal/neuroendocrine status.
- Subjects with a history of or current psychotic disorder or bipolar affective disorder as these may interfere with subjective measurements.
Show all 14Show fewer
- Subjects with current major depressive disorder or post-traumatic stress disorder as these disorders are associated with characteristic changes in stress response.
- Subjects with panic disorder, as yohimbine may precipitate panic attacks.
- 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 psychotropic medications,antidepressants, 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 who are obese (BMI>35) as this may interfere with hormonal status.
- 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.
- Subjects meeting DSM-IV criteria for substance dependence (other than nicotine, alcohol, marijuana or cocaine as appropriate) within the past 60 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina-GCRC
Charleston, South Carolina, 29425
About this study
Official title: SCOR on Sex and Gender Factors Affecting Women's Health
Stress and cues reminiscent of cocaine use promote craving and relapse in cocaine dependent individuals. In addition, there appears to be gender differences in determinants of relapse to drug use following abstinence in cocaine-dependent individuals. Therefore the purpose of the present study is to study the role of hormonal status on the response to cocaine-related cues with or without stress in cocaine-dependent women and men.
Read the detailed description
Cocaine dependence is an insidious disease underscored by a strong propensity to relapse despite knowledge of the repercussions of continued drug-use. Stress and cocaine cues produce craving and ultimately relapse in cocaine dependent individuals. Pre-clinical research has demonstrated sex differences in response to cocaine-conditioned cues and cocaine-primed reinstatement, which correlates well with reduced plasma progesterone levels. Interestingly, this is consistent with a growing body of clinical literature indicating that progesterone may decrease the reinforcing properties of stimulants in women. Gender differences in the response to a social stressor and cocaine cues in cocaine-dependent individuals have been demonstrated in human laboratory studies, however, the interaction of stress and cues and the effect of hormonal status on response have not been explored. This study examines the role of hormonal status on the response to cocaine-related cues with or without a pharmacological stressor (yohimbine) in cocaine-dependent women and men. As a further integration of the research focus this study also explores the relationship between impulsivity and craving.
- Conditions
- Cocaine Related Disorders
- Being tested
- Yohimbine, Placebo
- Keywords
- Cocaine Addiction, Cocaine Dependence
- Medical subject headings
- Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YohimbineDrug
Participants were pre-treated with either yohimbine or placebo.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Cocaine Females, Yohimbine then Placebo | Other | Cocaine dependent females, received yohimbine day 1 and placebo day 2 Receives: Drug: Yohimbine; Drug: Placebo |
| Cocaine Females, Placebo the Yohimbine | Other | Cocaine dependent females, received placebo day 1 and yohimbine day 2 Receives: Drug: Yohimbine; Drug: Placebo |
| Cocaine Males, Yohimbine then Placebo | Other | Cocaine dependent males, received yohimbine day 1 and placebo day 2 Receives: Drug: Yohimbine; Drug: Placebo |
| Cocaine Males, Placebo thenYohimbine | Other | Cocaine dependent males, received placebo day 1 and yohimbine day 2 Receives: Drug: Yohimbine; Drug: Placebo |
| Control Females, Yohimbine then Placebo | Other | Non-dependent females, received yohimbine day 1 and placebo day 2 Receives: Drug: Yohimbine; Drug: Placebo |
| Control Females, Placebo then Yohimbine | Other | Non-dependent females, received placebo day 1 and yohimbine day 2 Receives: Drug: Yohimbine; Drug: Placebo |
| Control Males, Yohimbine then Placebo | Other | Non-dependent males, received yohimbine day 1 and placebo day 2 Receives: Drug: Yohimbine; Drug: Placebo |
| Control Males, Placebo then Yohimbine | Other | Non-dependent males, received placebo day 1 and yohimbine day 2 Receives: Drug: Yohimbine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cocaine Craving
Cocaine-dependent participants were pre-treated with either yohimbine or placebo provided subjective ratings of cocaine craving immediately following cocaine cue exposure.
The scale used was the Within Sessions Ratings Scales (Childress AR, McLellan AT, O'Brien CP (1986) Conditioned responses in a methadone population. A comparison of laboratory, clinic, and natural settings. Journal of Substance Abuse Treatment 3:173-179.) Craving was rated on a scale of 0-10 with 0 being Not At All and 10 being Extremely.
Measured: Post cocaine cue exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionAug 2012
- Study completionAug 2012
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 Related DisordersStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Collaborators
- National Institute on Drug Abuse (NIDA), Office of Research on Women's Health (ORWH)
- Responsible party
- Sponsor
- Investigators
- Kathleen T Brady, M.D., Ph.D., Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00535002
- Sponsor's protocol ID
- P50DA016511-1
- Other IDs
- P50DA016511
- Status last verified
- Mar 2017
- First submitted
- 21 Sep 2007
- Last updated
- 7 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCOR on Sex and Gender Factors Affecting Women's Health
- ClinicalTrials.gov ID
- NCT00535002
- Acronym / sponsor ID
- P50DA016511-1
- Conditions
- Cocaine Related Disorders
- Keywords
- Cocaine Addiction, Cocaine Dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Office of Research on Women's Health (ORWH)
- Study start
- Sep 2007
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 26 Sep 2007 (estimated)
- Results
- Posted 7 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stress and cues reminiscent of cocaine use promote craving and relapse in cocaine dependent individuals. In addition, there appears to be gender differences in determinants of relapse to drug use following abstinence in cocaine-dependent individuals. Therefore the purpose of the present study is to study the role of hormonal status on the response to cocaine-related cues with or without stress in cocaine-dependent women and men.
Detailed description
Cocaine dependence is an insidious disease underscored by a strong propensity to relapse despite knowledge of the repercussions of continued drug-use. Stress and cocaine cues produce craving and ultimately relapse in cocaine dependent individuals. Pre-clinical research has demonstrated sex differences in response to cocaine-conditioned cues and cocaine-primed reinstatement, which correlates well with reduced plasma progesterone levels. Interestingly, this is consistent with a growing body of clinical literature indicating that progesterone may decrease the reinforcing properties of stimulants in women. Gender differences in the response to a social stressor and cocaine cues in cocaine-dependent individuals have been demonstrated in human laboratory studies, however, the interaction of stress and cues and the effect of hormonal status on response have not been explored. This study examines the role of hormonal status on the response to cocaine-related cues with or without a pharmacological stressor (yohimbine) in cocaine-dependent women and men. As a further integration of the research focus this study also explores the relationship between impulsivity and craving.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cocaine Females, Yohimbine then Placebo | Other | Drug: Yohimbine, Drug: PlaceboCocaine dependent females, received yohimbine day 1 and placebo day 2 |
| Cocaine Females, Placebo the Yohimbine | Other | Drug: Yohimbine, Drug: PlaceboCocaine dependent females, received placebo day 1 and yohimbine day 2 |
| Cocaine Males, Yohimbine then Placebo | Other | Drug: Yohimbine, Drug: PlaceboCocaine dependent males, received yohimbine day 1 and placebo day 2 |
| Cocaine Males, Placebo thenYohimbine | Other | Drug: Yohimbine, Drug: PlaceboCocaine dependent males, received placebo day 1 and yohimbine day 2 |
| Control Females, Yohimbine then Placebo | Other | Drug: Yohimbine, Drug: PlaceboNon-dependent females, received yohimbine day 1 and placebo day 2 |
| Control Females, Placebo then Yohimbine | Other | Drug: Yohimbine, Drug: PlaceboNon-dependent females, received placebo day 1 and yohimbine day 2 |
| Control Males, Yohimbine then Placebo | Other | Drug: Yohimbine, Drug: PlaceboNon-dependent males, received yohimbine day 1 and placebo day 2 |
| Control Males, Placebo then Yohimbine | Other | Drug: Yohimbine, Drug: PlaceboNon-dependent males, received placebo day 1 and yohimbine day 2 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- 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 consent to remain abstinent from all drugs of abuse (except nicotine) for a three-day period immediately prior to the CTRC admission. Nicotine dependence can affect HPA function (Baron et al., 1995) therefore it would be ideal to exclude subjects with nicotine use. Because of the high comorbidity of cocaine and nicotine dependence, this would seriously compromise the feasibility of recruitment. Individuals with alcohol dependence will be excluded. However because of the high comorbidity of alcohol use and cocaine dependence, individuals with alcohol abuse will be included. 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 with ADHD will be included. Because ADHD is commonly characterized by impulsivity, ADHD severity ratings will be determined and controlled for in data analysis.
- Subjects must consent to random assignment.
- Subjects must consent to outpatient admission to the CTRC and two overnight admissions to the Medical University Hospital.
Key exclusion criteria (14 listed)
- Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control.
- Women with premenstrual dysphoric disorder as this may impact on the response to the stress test procedure (Woods et al., 1994).
- Women receiving depot medroxyprogesterone acetate as a form of birth control.
- 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.
- Subjects with Addison's disease, Cushing's disease or other diseases of the adrenal cortex likely to affect hormonal/neuroendocrine status.
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 |
|---|---|---|
| YohimbineParticipants were pre-treated with either yohimbine or placebo. | Drug | Cocaine Females, Placebo the Yohimbine, Cocaine Females, Yohimbine then Placebo, Cocaine Males, Placebo thenYohimbine, Cocaine Males, Yohimbine then Placebo, Control Females, Placebo then Yohimbine, Control Females, Yohimbine then Placebo, Control Males, Placebo then Yohimbine, Control Males, Yohimbine then Placebo |
| Placebo | Drug | Cocaine Females, Placebo the Yohimbine, Cocaine Females, Yohimbine then Placebo, Cocaine Males, Placebo thenYohimbine, Cocaine Males, Yohimbine then Placebo, Control Females, Placebo then Yohimbine, Control Females, Yohimbine then Placebo, Control Males, Placebo then Yohimbine, Control Males, Yohimbine then Placebo |
Primary outcome
Cocaine Craving
Time frame: Post cocaine cue exposure
Cocaine-dependent participants were pre-treated with either yohimbine or placebo provided subjective ratings of cocaine craving immediately following cocaine cue exposure. The scale used was the Within Sessions Ratings Scales (Childress AR, McLellan AT, O'Brien CP (1986) Conditioned responses in a methadone population. A comparison of laboratory, clinic, and natural settings. Journal of Substance Abuse Treatment 3:173-179.) Craving was rated on a scale of 0-10 with 0 being Not At All and 10 being Extremely.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Cocaine Related Disorders
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
Recruiting
Transcranial Direct Current Stimulation (tDCS) for Treatment of Substance Use Disorder
Cocaine Use Disorder, Cocaine Dependence
Active, not recruitingEarly Phase 1
Targeting Drug Memories With Methylphenidate
Substance Use Disorder, Cocaine Use Disorder
RecruitingPhase 1
Safety Study of a Disrupted Adenovirus (Ad) Serotype Cocaine Vaccine for Cocaine-dependent Individuals
Cocaine Dependence
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.
Kathleen T Brady, M.D., Ph.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 Phase 2 study testing Yohimbine in people with Cocaine Related Disorders, 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 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 7 Jun 2017. 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. 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 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 7 Jun 2017). 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?
Cocaine Craving (time frame: Post cocaine cue exposure). 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 7 Jun 2017.