Cocaine DependencePhase 1NCT00780702
Aripiprazole for Prevention of Relapse to Cocaine Use in Methadone-Maintenance Patients
A Phase 1 study testing Airipiprazole in people with Cocaine Dependence and Cocaine-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
Background: The effectiveness of methadone maintenance for treatment of heroin addiction has been well established. However, patients maintained on methadone may relapse to cocaine use, even when they are enrolled in a comprehensive treatment program. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cocaine Dependence, Cocaine-Related Disorders, Opioid-Related Disorders
- What is being tested?
- Airipiprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2008to 16 Apr 2013
- Phase
- Phase 1
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 60
- Evidence of physical dependence on opioids (determined by self-report, urine screen, and physical exam)
- Evidence of (a) current cocaine use (determined by self-report and urine screen) or (b) cocaine dependence (DIS interview for DSM-IV criteria).
- Lifetime drug-use duration of at least 1 year and current cocaine use on at least 3 days of the last 30.
- Seeking treatment for opiate and cocaine use.
- Able to attend methadone clinic 7 days/week.
Who cannot join
- Any medical illness that in the view of the investigators would compromise participation in research (determined by Self-Reported Medical History; Physical Examination; Blood and Urine Laboratory tests; see details under Screening measures below), including, but not limited to:
- cardiovascular disease
- cerebrovascular disease
- unexplained history of syncope
- history of seizures, except for febrile seizures at childhood
- chronic renal failure, as estimated by Cr > 2.0
Show all 45Show fewer
- diabetes mellitus
- hyperlipidemia
- Allergy, hypersensitivity, or intolerance to either methadone or aripiprazole (determined by Self-Reported Medical History)
- AIDS, CD4 <200, or evidence of severely compromised immune system (determined by Blood Laboratory tests; see details under Screening measures below)
- Pregnancy or breastfeeding (Urine Pregnancy Test; self report)
- Orthostatic hypotension (i.e., upon standing for 3 minutes, a 20 mm Hg decrease in systolic blood pressure or a 10 mmHg decrease in diastolic blood pressure, accompanied by an increase by 20 bpm in heart rate) on two separate readings during physical examination.
- Marked, sustained high blood pressure (SBP >160 mm Hg, DBP >100 mm Hg) on two or more readings at a single visit and confirmed with two readings on a follow-up visit. If a participant is started on antihypertensive drugs at the start of the study, the participant may be cleared, but will not be started on aripiprazole until confirmation that the hypertension is well controlled (systolic blood pressure < 150, diastolic blood pressure < 100 mm Hg) on two readings at least 3 days apart.
- ECG abnormalities including QTc interval > 450 ms or changes suggesting acute ischemia, <TAB>second or third degree heart block, left bundle branch block, atrial fibrillation, or other <TAB>clinically important arrhythmias. ECGs may be sent to an outside cardiologist for manual <TAB>reading.
- Contraindicated medications (Self-Reported Medical History):
- Alpha-1 receptor blockers (e.g., doxazin, terazosin)
- Anti-epileptic medications (e.g., carbamazepine)
- Tricyclic antidepressants
- SSRIs
- Neuroleptics
- Quinidine
- Antifungals (e.g., ketoconazole)
- Ranolazine
- CYP3A4 inhibitors or inducers (other than methadone)
- CYP2D6 inhibitors or inducers (other than methadone)
- Family history (Self-Reported Medical History):
- Family history of sudden death of unexplained causes
- Sudden cardiac death
- Aneurysm
- Myocardial infarction below the age 50 years
- Psychiatric history:
- Cognitive impairment severe enough to preclude informed consent or valid responses on questionnaires (Shipley Institute of Living scale estimated full-scale IQ less than 80)
- History of schizophrenia or any other DSM-IV psychotic disorder (Self-Reported Medical History; Diagnostic Interview Schedule for the DSM-IV (DIS IV))
- History of bipolar disorder (Self-Reported Medical History; DIS IV)
- Current Major Depressive Disorder (Self-Reported Medical History; DIS IV)
- Previous suicide attempts or ideation (Self-Reported Medical History; DIS-IV)
- Dementia (DIS-IV; Clinical Interview; Shipley Institute of Living scale)
- Current physical dependence on alcohol or sedative-hypnotics, e.g. benzodiazepines (self-report; ASI; alcohol CAGE questions; and pattern of positive drug screens or BAL for alcohol)
- Body Mass Index (BMI) over 40
- Failure to agree to use a medically effective form of contraception while in the study (in women who are sexually active with a male partner and able to get pregnant). Acceptable forms of contraception for this study include:
- hormonal contraceptives (birth control pills, injectable hormones, vaginal ring hormones),
- surgical sterility (tubal ligation or hysterectomy)
- IUD
- Diaphragm with spermicide
- Condom with spermicide
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute on Drug Abuse
Baltimore, Maryland, 21224
About this study
Background:
- The effectiveness of methadone maintenance for treatment of heroin addiction has been well established. However, patients maintained on methadone may relapse to cocaine use, even when they are enrolled in a comprehensive treatment program. Relapse has been attributed to several factors, including drug-associated environmental stimuli.
- Aripiprazole is a drug used to treat schizophrenia and bipolar disorder, but it may have other uses. Research has shown that aripiprazole can reduce cocaine-seeking behavior in rats, and it has been investigated for use in treating amphetamine dependence. More research is needed to determine whether aripiprazole can prevent relapse to cocaine use in patients being treated with methadone.
Read more
Objectives:
- To determine whether aripiprazole prevents relapse to cocaine use more effectively than placebo in cocaine-abstinent patients maintained on methadone.
Eligibility:
- Individuals between 18 and 60 years of age who are current cocaine users seeking methadone treatment.
Design:
- The study will last up to 41 weeks, with four phases of treatment and a follow-up evaluation. Three times a week, participants will be asked to report illicit drug use and provide urine and breath samples. Throughout the study, participants will receive individual counseling in weekly 40 60 minute sessions. Other samples and tests will be scheduled as required by the study researchers.
- Patients will be stabilized on daily methadone over the first 14 days of the study.
- Weeks 1 14: Participants will receive vouchers for regular cocaine-free urine samples. Those who successfully complete this phase will continue to the next part of the study.
- Weeks 13 27: Participants will receive either aripiprazole or placebo along with their methadone. During this part of the study, participants will keep electronic diaries to record cocaine use or craving and to record data on mood and activity.
- Weeks 28 33: Participants will stop taking the aripiprazole or placebo, but will continue the methadone treatment. Participants will continue to use the electronic diaries.
- Weeks 34 41: Participants will have the choice of transferring to a community clinic or gradually reducing doses of methadone to end the study.
- Participants will return for a follow-up visit and urine sample 6 months after the end of the study.
Read the detailed description
Background. Though methadone effectively treats opioid dependence in polydrug users, some abstinent patients relapse to maladaptive use of cocaine during treatment. Relapse may be triggered by cocaine-associated cues. Work in a rodent relapse model has demonstrated that the atypical neuroleptic drug aripiprazole (Abilify), a partial agonist at dopamine D2 receptors, can block relapse to cocaine use induced by cocaine-associated environmental stimuli or by priming doses of cocaine.
Scientific goals. To determine whether aripiprazole prevents relapse to cocaine use more effectively than placebo in cocaine-abstinent patients maintained on methadone.
Participant population. A total of up to 275 opioid-dependent outpatients abusing cocaine and opioids (110 evaluable) will be enrolled. Target enrollment will include 40% women and 60% minorities (mostly African-American).
Experimental design and methods. The study will be a randomized double-blind clinical trial with two treatment groups (55 per group): aripiprazole (15 mg oral daily) and placebo. All patients will receive standard treatment (methadone daily and individual counseling weekly) for 39 weeks. To establish abstinence prior to aripiprazole induction, contingent vouchers will be given for each cocaine-negative urine specimen during the first 12 weeks (weeks 1-12). Participants who are abstinent from cocaine during weeks 11 and 12 will be randomized to receive aripiprazole or aripiprazole placebo in weeks 13 through 27 (induction, weeks 13 and 14; taper, week 27). From weeks 28-33, participants will receive methadone and counseling only, and then will be offered assistance to transfer to another program; those who do not transfer will undergo an 8-week methadone detoxification. The primary outcome measures will be time to relapse and longest duration of cocaine abstinence. Secondary objectives include evaluating whether the treatment groups differ in self-reported changes in drug use and proportion of drug-negative urine specimens. In addition, drug use, drug craving, stress, and HIV-risk behaviors such as injection practices will be assessed via electronic diaries (ecological momentary assessment, EMA).
Benefits to participants and/or society. Participants will receive methadone, drug counseling, and contingency-management therapy. The methadone, counseling, and voucher interventions are likely to reduce participants use of heroin and cocaine and HIV risk behaviors. Aripiprazole may reduce the incidence of relapse to cocaine use.
Risks to participants. Participants may experience side effects from aripiprazole and methadone and discomfort during withdrawal from methadone and aripiprazole. Methadone could raise serum levels of aripiprazole via inhibition of CYP2D6 metabolic pathways. The EMA component of the study may generate some assessment burden.
- Being tested
- Airipiprazole, Placebo
- Keywords
- Cocaine, Treatment, Airpiprazole, Methadone, Relapse, HIV, Ecological Momentary Assessment (EMA), Contingency Management
- Medical subject headings
- Cocaine-Related Disorders, Opioid-Related Disorders, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AiripiprazoleDrug
Participants receive aripiprazole (orally, up to 15 mg/day) plus standard methadone maintenance (daily oral methadone and weekly individual counseling).
PlaceboDrug
Participants receive identical capsules containing no active medication plus standard methadone maintenance (daily oral methadone and weekly individual counseling).
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Airipiprazole |
| Arm 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to relapse
Measured: 19 weeks
Secondary outcomes (2)
Cocaine use
Measured: 19 weeks
HIV risk behaviors
Measured: 19 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2008 (estimated)
- Study start8 May 2008
- Primary completion16 Apr 2013
- Study completion16 Apr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Kenzie Preston, Ph.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00780702
- Sponsor's protocol ID
- 999908426
- Other IDs
- 08-DA-N426
- Status last verified
- 27 Feb 2014
- First submitted
- 27 Oct 2008
- Last updated
- 16 Dec 2019
- Results posted
- No
Publications
Bjornsson TD, Callaghan JT, Einolf HJ, Fischer V, Gan L, Grimm S, Kao J, King SP, Miwa G, Ni L, Kumar G, McLeod J, Obach SR, Roberts S, Roe A, Shah A, Snikeris F, Sullivan JT, Tweedie D, Vega JM, Walsh J, Wrighton SA; Pharmaceutical Research and Manufacturers of America Drug Metabolism/Clinical Pharmacology Technical Working Groups. The conduct of in vitro and in vivo drug-drug interaction studies: a PhRMA perspective. J Clin Pharmacol. 2003 May;43(5):443-69.
PubMed 12751267Childress AR, O'Brien CP. Dopamine receptor partial agonists could address the duality of cocaine craving. Trends Pharmacol Sci. 2000 Jan;21(1):6-9. doi: 10.1016/s0165-6147(99)01422-4. No abstract available.
PubMed 10637646Conley RR, Kelly DL, Gale EA. Olanzapine response in treatment-refractory schizophrenic patients with a history of substance abuse. Schizophr Res. 1998 Sep 7;33(1-2):95-101. doi: 10.1016/s0920-9964(98)00062-0.
PubMed 9783349
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aripiprazole for Prevention of Relapse to Cocaine Use in Methadone-Maintenance Patients
- ClinicalTrials.gov ID
- NCT00780702
- Acronym / sponsor ID
- 999908426
- Keywords
- Cocaine, Treatment, Airpiprazole, Methadone, Relapse, HIV, Ecological Momentary Assessment (EMA), Contingency Management
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 8 May 2008
- Primary completion
- 16 Apr 2013 (actual)
- Study completion
- 16 Apr 2013 (actual)
- First posted
- 28 Oct 2008 (estimated)
- 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.
Background:
- The effectiveness of methadone maintenance for treatment of heroin addiction has been well established. However, patients maintained on methadone may relapse to cocaine use, even when they are enrolled in a comprehensive treatment program. Relapse has been attributed to several factors, including drug-associated environmental stimuli.
- Aripiprazole is a drug used to treat schizophrenia and bipolar disorder, but it may have other uses. Research has shown that aripiprazole can reduce cocaine-seeking behavior in rats, and it has been investigated for use in treating amphetamine dependence. More research is needed to determine whether aripiprazole can prevent relapse to cocaine use in patients being treated with methadone.
Objectives:
- To determine whether aripiprazole prevents relapse to cocaine use more effectively than placebo in cocaine-abstinent patients maintained on methadone.
Eligibility:
- Individuals between 18 and 60 years of age who are current cocaine users seeking methadone treatment.
Design:
- The study will last up to 41 weeks, with four phases of treatment and a follow-up evaluation. Three times a week, participants will be asked to report illicit drug use and provide urine and breath samples. Throughout the study, participants will receive individual counseling in weekly 40 60 minute sessions. Other samples and tests will be scheduled as required by the study researchers.
- Patients will be stabilized on daily methadone over the first 14 days of the study.
- Weeks 1 14: Participants will receive vouchers for regular cocaine-free urine samples. Those who successfully complete this phase will continue to the next part of the study.
- Weeks 13 27: Participants will receive either aripiprazole or placebo along with their methadone. During this part of the study, participants will keep electronic diaries to record cocaine use or craving and to record data on mood and activity.
- Weeks 28 33: Participants will stop taking the aripiprazole or placebo, but will continue the methadone treatment. Participants will continue to use the electronic diaries.
- Weeks 34 41: Participants will have the choice of transferring to a community clinic or gradually reducing doses of methadone to end the study.
- Participants will return for a follow-up visit and urine sample 6 months after the end of the study.
Detailed description
Background. Though methadone effectively treats opioid dependence in polydrug users, some abstinent patients relapse to maladaptive use of cocaine during treatment. Relapse may be triggered by cocaine-associated cues. Work in a rodent relapse model has demonstrated that the atypical neuroleptic drug aripiprazole (Abilify), a partial agonist at dopamine D2 receptors, can block relapse to cocaine use induced by cocaine-associated environmental stimuli or by priming doses of cocaine.
Scientific goals. To determine whether aripiprazole prevents relapse to cocaine use more effectively than placebo in cocaine-abstinent patients maintained on methadone.
Participant population. A total of up to 275 opioid-dependent outpatients abusing cocaine and opioids (110 evaluable) will be enrolled. Target enrollment will include 40% women and 60% minorities (mostly African-American).
Experimental design and methods. The study will be a randomized double-blind clinical trial with two treatment groups (55 per group): aripiprazole (15 mg oral daily) and placebo. All patients will receive standard treatment (methadone daily and individual counseling weekly) for 39 weeks. To establish abstinence prior to aripiprazole induction, contingent vouchers will be given for each cocaine-negative urine specimen during the first 12 weeks (weeks 1-12). Participants who are abstinent from cocaine during weeks 11 and 12 will be randomized to receive aripiprazole or aripiprazole placebo in weeks 13 through 27 (induction, weeks 13 and 14; taper, week 27). From weeks 28-33, participants will receive methadone and counseling only, and then will be offered assistance to transfer to another program; those who do not transfer will undergo an 8-week methadone detoxification. The primary outcome measures will be time to relapse and longest duration of cocaine abstinence. Secondary objectives include evaluating whether the treatment groups differ in self-reported changes in drug use and proportion of drug-negative urine specimens. In addition, drug use, drug craving, stress, and HIV-risk behaviors such as injection practices will be assessed via electronic diaries (ecological momentary assessment, EMA).
Benefits to participants and/or society. Participants will receive methadone, drug counseling, and contingency-management therapy. The methadone, counseling, and voucher interventions are likely to reduce participants use of heroin and cocaine and HIV risk behaviors. Aripiprazole may reduce the incidence of relapse to cocaine use.
Risks to participants. Participants may experience side effects from aripiprazole and methadone and discomfort during withdrawal from methadone and aripiprazole. Methadone could raise serum levels of aripiprazole via inhibition of CYP2D6 metabolic pathways. The EMA component of the study may generate some assessment burden.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Airipiprazole |
| Arm 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
Key exclusion criteria (45 listed)
- Any medical illness that in the view of the investigators would compromise participation in research (determined by Self-Reported Medical History; Physical Examination; Blood and Urine Laboratory tests; see details under Screening measures below), including, but not limited to:
- Allergy, hypersensitivity, or intolerance to either methadone or aripiprazole (determined by Self-Reported Medical History)
- AIDS, CD4 <200, or evidence of severely compromised immune system (determined by Blood Laboratory tests; see details under Screening measures below)
- Pregnancy or breastfeeding (Urine Pregnancy Test; self report)
- Orthostatic hypotension (i.e., upon standing for 3 minutes, a 20 mm Hg decrease in systolic blood pressure or a 10 mmHg decrease in diastolic blood pressure, accompanied by an increase by 20 bpm in heart rate) on two separate readings during physical examination.
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 |
|---|---|---|
| AiripiprazoleParticipants receive aripiprazole (orally, up to 15 mg/day) plus standard methadone maintenance (daily oral methadone and weekly individual counseling). | Drug | Arm 1 |
| PlaceboParticipants receive identical capsules containing no active medication plus standard methadone maintenance (daily oral methadone and weekly individual counseling). | Drug | Arm 2 |
Primary outcome
Time to relapse
Time frame: 19 weeks
2 secondary outcomes
Cocaine use
Time frame: 19 weeks
HIV risk behaviors
Time frame: 19 weeks
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 16 Dec 2019.
- Background: PubMed 12751267Bjornsson TD, Callaghan JT, Einolf HJ, Fischer V, Gan L, Grimm S, Kao J, King SP, Miwa G, Ni L, Kumar G, McLeod J, Obach SR, Roberts S, Roe A, Shah A, Snikeris F, Sullivan JT, Tweedie D, Vega JM, Walsh J, Wrighton SA; Pharmaceutical Research and Manufacturers of America Drug Metabolism/Clinical Pharmacology Technical Working Groups. The conduct of in vitro and in vivo drug-drug interaction studies: a PhRMA perspective. J Clin Pharmacol. 2003 May;43(5):443-69.
- Background: PubMed 10637646Childress AR, O'Brien CP. Dopamine receptor partial agonists could address the duality of cocaine craving. Trends Pharmacol Sci. 2000 Jan;21(1):6-9. doi: 10.1016/s0165-6147(99)01422-4. No abstract available.
- Background: PubMed 9783349Conley RR, Kelly DL, Gale EA. Olanzapine response in treatment-refractory schizophrenic patients with a history of substance abuse. Schizophr Res. 1998 Sep 7;33(1-2):95-101. doi: 10.1016/s0920-9964(98)00062-0.
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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.
Kenzie Preston, Ph.D. principal investigator
National Institute on Drug Abuse (NIDA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Airipiprazole in people with Cocaine Dependence and Cocaine-Related Disorders, run by National Institute on Drug Abuse (NIDA) 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 6 inclusion and 45 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 16 Dec 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.
What does this 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.
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?
Time to relapse (time frame: 19 weeks). 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 NCT00780702, which also lists 3 linked publications.
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 16 Dec 2019.