Cocaine Related DisordersPhase 2NCT00613015
Stress and Medication Effects on Cocaine Cue Reactivity
A Phase 2 study testing Guanfacine and Modafinil in people with Cocaine Related Disorders, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Stressful situations and cues associated with cocaine can lead to craving in cocaine dependent individuals. The purpose of this study is to determine whether guanfacine or modafinil are effective in reducing stress and cue induced craving in cocaine dependent individuals. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cocaine Related Disorders
- What is being tested?
- Guanfacine and Modafinil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Jul 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
- 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 consent to remain abstinent from all drugs of abuse (except nicotine) during the GCRC admission.
- Because of the high comorbidity of alcohol and marijuana use and cocaine dependence, individuals meeting dependence for alcohol and marijuana will be included. Individuals requiring medical detox from alcohol will be excluded.
- Subjects must consent to random assignment to stress vs. no stress and drug treatment conditions.
Who cannot join
- Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control. Modafinil inhibits metabolism of steroidal contraceptives via CYP3A4 and can reduce the effectiveness of this type of birth control, female subjects must use one of the following methods of birth control: barrier methods (diaphragm or condoms with spermicide or both), surgical sterilization, use of an intra-uterine contraceptive device, or complete abstinence from sexual intercourse.
- Subjects with evidence of or a history of significant hematological, endocrine, cardiovascular (including but not limited to left ventricular hypertrophy (unless a cardiologist deems that it is not clinically significant), mitral valve prolapse, left bundle branch block, myocardial infarction, and angina), pulmonary, renal, gastrointestinal, or neurological disease including diabetes, as these conditions may affect HPA axis function.
- Subjects with any liver function test (LFTs) of greater than two times normal, as compromised liver function can interfere with HPA axis activity (Williams and Dluhy 1987) and may affect drug metabolism.
- Subjects with Addison's disease, Cushing's disease or other diseases of the adrenal cortex likely to affect HPA axis function.
- Subjects with a history of or current psychotic disorder or bipolar affective disorder as these may interfere with HPA function.
- Subjects with current major depressive disorder or post-traumatic stress disorder as these disorders are associated with characteristic changes in HPA axis function.
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- Subjects receiving synthetic glucocorticoid therapy, any exogenous steroid therapy, or treatment with other agents that interfere with HPA axis function within one month of the time of testing.
- Subjects taking any psychotropic medications, opiates or opiate antagonists because these may affect HPA axis function.Participants taking SSRI's will be included.
- Subjects required to take medications that could adversely interact with study medications, including, but not limited to, azole type antifungals, cyclosporine, warfarin, theophylline, or carbamazepine. Any medications that induce or inhibit CYP3A4 pathways are excluded, as modafinil is metabolized through this enzyme system.
- Subjects with any acute illness or fever as this may affect HPA axis activity. Individuals who otherwise meet study criteria will be rescheduled for evaluation for participation.
- Subjects who are grossly obese (BMI > 39), as this may interfere with HPA axis function.
- Subjects who are unwilling or unable to maintain abstinence from alcohol and other drugs of abuse (except nicotine) prior to the stress task procedure.
- 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-GCRC
Charleston, South Carolina, 29425
About this study
Official title: Interdisciplinary Medication Development for Multiple Risk Factors in Relapse.
Stressful situations and cues associated with cocaine can lead to craving in cocaine dependent individuals. The purpose of this study is to determine whether guanfacine or modafinil are effective in reducing stress and cue induced craving in cocaine dependent individuals.
Read the detailed description
Stress and cocaine cues produce craving and ultimately relapse in cocaine dependent individuals. This is a randomized, double-blind, placebo-controlled study evaluating the effects of either guanfacine (Tenex) or modafinil (Provigil) on stress and cue induced craving in cocaine dependent individuals. Cocaine dependence will be assessed in adults (ages 18-65) as defined by DSM-IV criteria. If the subject signs the consent form, meets the study criteria and does not meet the exclusion criteria they will be included in the study. Subjects will report to the General Clinical Research Center (GCRC) at the Medical University of South Carolina (MUSC), for an outpatient visit and will receive their first dose of study medication. The following day subjects will return to the GCRC and admitted for the duration of the study (two days and one night). There will be a one-week and a one-month follow-up visit. Subjects will be randomly assigned to one of two treatment groups (guanfacine or placebo). Each subject will also be randomly assigned to either a stress or no-stress subgroup. On the test day (day 3) subjects in the stress group will be asked to perform a speech and a math problem in front of an audience (Trier Social Stress Test, TSST), while the no-stress group will be asked to sit quietly and read. Following these tasks, each subject will be exposed to neutral (control) cues and immediately afterwards the subjects will be exposed to cocaine cues (cocaine paraphernalia). Craving/mood, physiological activity, and endocrine responses, will be assessed at pre-set intervals throughout the testing procedure. The cue reactivity protocol will be repeated on the one-week follow-up visit.
- Conditions
- Cocaine Related Disorders
- Being tested
- Guanfacine, Modafinil, 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.
GuanfacineDrug
ModafinilDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Modafinil/Stress | Experimental | Participants received placebo for 2 days. modafinil on the third day and participated in the TRIER social stress task on the third day. Receives: Drug: Modafinil |
| Modafinil/no stress | Experimental | Participants received placebo for 2 days. modafinil on the third day and did not participate in the TRIER social stress task on the third day. Receives: Drug: Modafinil |
| Guanfacine/stress | Experimental | Participants received guanfacine for 3 days and participated in the TRIER social stress task on the third day. Receives: Drug: Guanfacine |
| Guanfacine/no stress | Experimental | Participants received guanfacine for 3 days and did not participate in the TRIER social stress task on the third day. Receives: Drug: Guanfacine |
| Placebo/Stress | Placebo comparator | Participants received placebo for 3 days and participated in the TRIER social stress task on the third day. Receives: Drug: Placebo |
| Placebo/no stress | Placebo comparator | Participants received placebo for 3 days and did not participate in the TRIER social stress task on the third day. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cocaine Craving
Participants were randomized to the modafinil, guanfacine, or placebo treatment group. Participants were then randomized to participate in the TRIER social stress task or to read magazines for 15 minutes. Following the task, participants were exposed to neutral cues for 2 minutes and cocaine cues for 2 minutes. Immediately following the cocaine cue exposure, participants were asked to rate cocaine craving on a 10-point Likert scale, with 0 being Not at All and 10 being Extremely.
Measured: Post Trier social stress task + Cocaine Cue 2:30 pm
Secondary outcomes (1)
Cortisol- 2:30 pm, Immediately Following Trier Social Stress Task + Cocaine Cue Exposure
Participants were randomized to receive to the modafinil, guanfacine, or placebo treatment group. Participants were then randomized to complete a TRIER social stress task or read magazines for 15 minutes. Following the task, participants were exposed to neutral cues for two minutes and control cues for two minutes. Immediately following exposure to the cocaine cue, saliva samples were collected to measure cortisol levels.
Measured: Immediately following trier + 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 posted12 Feb 2008 (estimated)
- Study startMay 2008
- Primary completionJul 2012
- Study completionJul 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 109 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)
- Responsible party
- Sponsor
- Investigators
- Ronald E See, Ph.D., Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00613015
- Sponsor's protocol ID
- R01DA021690
- Other IDs
- R01DA021690
- Status last verified
- May 2018
- First submitted
- 8 Feb 2008
- Last updated
- 4 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interdisciplinary Medication Development for Multiple Risk Factors in Relapse.
- ClinicalTrials.gov ID
- NCT00613015
- Acronym / sponsor ID
- R01DA021690
- Conditions
- Cocaine Related Disorders
- Keywords
- Cocaine Addiction, Cocaine Dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- May 2008
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 12 Feb 2008 (estimated)
- Results
- Posted 8 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stressful situations and cues associated with cocaine can lead to craving in cocaine dependent individuals. The purpose of this study is to determine whether guanfacine or modafinil are effective in reducing stress and cue induced craving in cocaine dependent individuals.
Detailed description
Stress and cocaine cues produce craving and ultimately relapse in cocaine dependent individuals. This is a randomized, double-blind, placebo-controlled study evaluating the effects of either guanfacine (Tenex) or modafinil (Provigil) on stress and cue induced craving in cocaine dependent individuals. Cocaine dependence will be assessed in adults (ages 18-65) as defined by DSM-IV criteria. If the subject signs the consent form, meets the study criteria and does not meet the exclusion criteria they will be included in the study. Subjects will report to the General Clinical Research Center (GCRC) at the Medical University of South Carolina (MUSC), for an outpatient visit and will receive their first dose of study medication. The following day subjects will return to the GCRC and admitted for the duration of the study (two days and one night). There will be a one-week and a one-month follow-up visit. Subjects will be randomly assigned to one of two treatment groups (guanfacine or placebo). Each subject will also be randomly assigned to either a stress or no-stress subgroup. On the test day (day 3) subjects in the stress group will be asked to perform a speech and a math problem in front of an audience (Trier Social Stress Test, TSST), while the no-stress group will be asked to sit quietly and read. Following these tasks, each subject will be exposed to neutral (control) cues and immediately afterwards the subjects will be exposed to cocaine cues (cocaine paraphernalia). Craving/mood, physiological activity, and endocrine responses, will be assessed at pre-set intervals throughout the testing procedure. The cue reactivity protocol will be repeated on the one-week follow-up visit.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Modafinil/Stress | Experimental | Drug: ModafinilParticipants received placebo for 2 days. modafinil on the third day and participated in the TRIER social stress task on the third day. |
| Modafinil/no stress | Experimental | Drug: ModafinilParticipants received placebo for 2 days. modafinil on the third day and did not participate in the TRIER social stress task on the third day. |
| Guanfacine/stress | Experimental | Drug: GuanfacineParticipants received guanfacine for 3 days and participated in the TRIER social stress task on the third day. |
| Guanfacine/no stress | Experimental | Drug: GuanfacineParticipants received guanfacine for 3 days and did not participate in the TRIER social stress task on the third day. |
| Placebo/Stress | Placebo comparator | Drug: PlaceboParticipants received placebo for 3 days and participated in the TRIER social stress task on the third day. |
| Placebo/no stress | Placebo comparator | Drug: PlaceboParticipants received placebo for 3 days and did not participate in the TRIER social stress task on the third day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 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) during the GCRC admission.
- Because of the high comorbidity of alcohol and marijuana use and cocaine dependence, individuals meeting dependence for alcohol and marijuana will be included. Individuals requiring medical detox from alcohol will be excluded.
- Subjects must consent to random assignment to stress vs. no stress and drug treatment conditions.
Key exclusion criteria (13 listed)
- Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control. Modafinil inhibits metabolism of steroidal contraceptives via CYP3A4 and can reduce the effectiveness of this type of birth control, female subjects must use one of the following methods of birth control: barrier methods (diaphragm or condoms with spermicide or both), surgical sterilization, use of an intra-uterine contraceptive device, or complete abstinence from sexual intercourse.
- Subjects with evidence of or a history of significant hematological, endocrine, cardiovascular (including but not limited to left ventricular hypertrophy (unless a cardiologist deems that it is not clinically significant), mitral valve prolapse, left bundle branch block, myocardial infarction, and angina), pulmonary, renal, gastrointestinal, or neurological disease including diabetes, as these conditions may affect HPA axis function.
- Subjects with any liver function test (LFTs) of greater than two times normal, as compromised liver function can interfere with HPA axis activity (Williams and Dluhy 1987) and may affect drug metabolism.
- Subjects with Addison's disease, Cushing's disease or other diseases of the adrenal cortex likely to affect HPA axis function.
- Subjects with a history of or current psychotic disorder or bipolar affective disorder as these may interfere with HPA function.
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 |
|---|---|---|
| Guanfacine | Drug | Guanfacine/no stress, Guanfacine/stress |
| Modafinil | Drug | Modafinil/Stress, Modafinil/no stress |
| Placebo | Drug | Placebo/Stress, Placebo/no stress |
Primary outcome
Cocaine Craving
Time frame: Post Trier social stress task + Cocaine Cue 2:30 pm
Participants were randomized to the modafinil, guanfacine, or placebo treatment group. Participants were then randomized to participate in the TRIER social stress task or to read magazines for 15 minutes. Following the task, participants were exposed to neutral cues for 2 minutes and cocaine cues for 2 minutes. Immediately following the cocaine cue exposure, participants were asked to rate cocaine craving on a 10-point Likert scale, with 0 being Not at All and 10 being Extremely.
1 secondary outcome
Cortisol- 2:30 pm, Immediately Following Trier Social Stress Task + Cocaine Cue Exposure
Time frame: Immediately following trier + cocaine cue exposure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
- 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.
Ronald E See, 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 Guanfacine and Modafinil 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 4 inclusion and 13 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 4 Jun 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 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 8 Nov 2013). 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 Trier social stress task + Cocaine Cue 2:30 pm). 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 4 Jun 2018.