CannabisPhase 1NCT01041170
Antagonist-Elicited Cannabis Withdrawal
A Phase 1 study testing THC, Rimonobant and Rimonabant in people with Cannabis and Dependence, run by National Institute on Drug Abuse (NIDA) at 2 sites in United States.
Trial summary
Background: Rimonabant, a CB1 receptor antagonist, blocks effects of cannabinoids and, in dependent animals, elicits cannabinoid withdrawal. No studies have examined rimonabantelicited cannabis withdrawal in humans. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Cannabis, Dependence
- What is being tested?
- THC, Rimonobant and Rimonabant
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- 16 Apr 2006to 11 Jan 2010
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18 to 45 years of age;
- Cannabis use of at least one year with a typical pattern of daily use for the three months prior to unit admission;
- A urine sample positive for cannabinoids in the 30 days prior to study enrollment;
- Blood pressure (BP) and heart rate (HR) at or below the following values while sitting after 5 minutes' rest: Systolic BP (SBP) 140 mm Hg, diastolic BP (DBP) 90 mm Hg,
- heart rate (HR) 100 bpm;
- 12-lead standard ECG and 3-minute rhythm strip without clinically relevant abnormalities and within the limits defined for the protocol in Appendix 2;
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- Peripheral veins suitable for repeated venipuncture and placement and maintenance of an IV catheter;
- Ability to swallow capsules;
- Ability to communicate well with the investigators and to comply with study requirements;
- Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (beta-HCG) pregnancy test prior to study enrollment. All volunteers must use an intra-uterine device or hormonal contraception during the entire study period and for 1 month after. Women who are postmenopausal for more than 12 months or who were sterilized more than 3 months ago are not considered to have childbearing potential;
- Estimated IQ greater than or equal to 85 determined by the Wechsler Abbreviated Scale of Intelligence
- Right-handed (Experiment II only).
- 18 to 45 years of age;
- BP and HR at or below the following values while sitting after five minutes' rest: SBP 140 mm Hg, DBP 90 mm Hg, HR 100 bpm;
- Ability to communicate well with the investigator and to comply with study requirements;
- If female with reproductive potential, must be using a reliable method of birth control
- Estimated IQ greater than or equal to 85 determined by the Wechsler Abbreviated Scale of Intelligence;
- Right-handed
Who cannot join
- History or presence of any clinically significant disease state, as detected by history, physical examination, and/or laboratory tests, that might put the subject at increased risk of adverse events or that might interfere with the absorption, distribution, metabolism, or excretion of study drugs;
- Current physical dependence on any substance other than cannabis, nicotine, or caffeine;
- Positive serological tests for syphilis or HIV infection;
- Positive purified protein derivative (PPD) test in the absence of a negative chest Xray;
- Consumption of an investigational drug within 90 days prior to study drug administration;
- Consumption of any drug at a dose known to have a well-defined potential for toxicity to a major organ system within 3 months prior to study drug administration;
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- Symptoms of a clinically significant1 illness within two weeks prior to study drug administration;
- History of a clinically significant1 adverse event associated with cannabis intoxication or withdrawal;
- History of epileptic seizures or head trauma with loss of consciousness greater than three minutes;
- History of psychosis or any current DSM-IV axis I disorder (other than cannabis, caffeine or nicotine dependence, or simple phobia);
- Donation of more than 500 mL of blood within 30 days of study drug administration;
- Regular use of alcohol (greater than or equal to 6 standard drinks per day) four or more times per week in the month prior to study entry;
- If female, pregnant or nursing;
- ADHD Screening Rating Scale score greater than or equal to 24 on either the A or B subscale;
- Allergy to sesame seed oil (ingredient in dronabinol capsules);
- Currently interested in or participating in drug abuse treatment, or participated in drug abuse treatment within 60 days preceding study enrollment.
- Claustrophobia that precludes being able to tolerate an fMRI session (Experiment II only).
- Magnetizable metal on or within the body that cannot be removed (Experiment II only).
- Eligibility Criteria for Controls
- The goal of the eligibility criteria for control subjects is to obtain a group approximately comparable to the cannabis users in terms of age, sex, ethnicity, and intelligence.
- History or presence of any clinically significant disease state, as detected by history, physical examination, and/or laboratory tests that might put the subject at increased risk of adverse events;
- A positive urine test for any illicit drug at any time during screening or study participation;
- Current physical dependence on any substance other than nicotine or caffeine;
- Self-reported lifetime use of any illicit drug other than cannabis;
- Self-reported lifetime use of cannabis greater than ten times or use within the last two years;
- Positive serological tests for syphilis or HIV infection;
- History of epileptic seizures or head trauma with loss of consciousness greater than three minutes;
- History of psychosis or any current DSM-IV axis I disorder (other than caffeine or nicotine dependence, or simple phobia);
- Regular use of alcohol (greater than or equal to 6 standard drinks per day) four or more times per week in the month prior to study entry;
- If female, pregnant or nursing;
- ADHD Screening Rating Scale score greater than or equal to 24 on either the A or B subscale;
- Claustrophobia that precludes being able to tolerate an fMRI session;
- Magnetizable metal on or within the body that cannot be removed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Maryland, Baltimore
Baltimore, Maryland, 21201-1595
National Institute on Drug Abuse, Biomedical Research Center (BRC)
Baltimore, Maryland, 21224
About this study
Background: Rimonabant, a CB1 receptor antagonist, blocks effects of cannabinoids and, in dependent animals, elicits cannabinoid withdrawal. No studies have examined rimonabantelicited cannabis withdrawal in humans.
Goals: (1) Determine the lowest single dose of oral rimonabant that elicits measurable cannabinoid withdrawal. (2) Characterize cognitive performance, subjective state, physiological condition, and regional brain activation (measured by functional magnetic resonance imaging [fMRI]) during acute and chronic administration of oral delta 9-tetrahydrocannabinol (THC) and during cannabis withdrawal. (3) Characterize the pharmacokinetics of oral THC and metabolites in body fluids and hair and of rimonabant in plasma.
Read more
Subject Population: Up to 60 completing cannabis users aged 18-45 (up to 24 in Experiment I, 36 in Experiment II) and 18 completing non-drug-using controls (Experiment II). Enrollment target is 82% Caucasian, 14% African American, 4% other; 9% Hispanic; 35% women.
Experimental Design and Methods: Experiment I: In this within-subject, randomized, double-blind, dose-escalation study, six participants receive 7 days of THC (40-120 mg/day). On Day 8, five participants receive 20 mg rimonabant; one receives placebo. If withdrawal criteria (greater than or equal to 150% or 2.5-fold increase in selected visual-analog scales) are not met in all five participants receiving rimonabant, separate groups of six are similarly treated with 40, 60 or 80 mg rimonabant, if necessary. The PI and MRP will submit all adverse events and relevant cardiovascular and scientific data to the IRB at the completion of each rimonabant dose panel. When the extramural NIDA DSMB is in place, it will review all data collected to date and develop and implement a monitoring plan, including review on completion of each dose cohort. DSMB recommendations will be reviewed by the Sponsor, Clinical Director and IRB before proceeding to the next dose cohort. In addition, if any subject has an intolerable adverse event (ie, an adverse event leading to study discontinuation) or serious adverse event in response to rimonabant on Day 8, the blind for that subject will be broken, and a report sent to the Sponsor, the extramural NIDA DSMB when in place and the IRB for discussion.
Experiment II: In this randomized, placebo-controlled, double-blind study, 36 participants receive 7 days of THC (40-120 mg/day). On Day 8, 18 participants receive rimonabant dose determined in Experiment I to elicit cannabis withdrawal; 18 participants receive placebo rimonabant to evaluate spontaneous cannabis withdrawal. Cognitive, psychological, physiological and hormonal measures are monitored to determine onset, magnitude, and duration of THC intoxication and withdrawal and to correlate with THC and rimonabant pharmacokinetics. Changes in blood oxygen level-dependent (BOLD) signal are determined with five fMRI scans throughout the study. Eighteen non-drug-using controls undergo scanning and cognitive testing at similar intervals.
Risks and Benefits: The proposed doses of THC and rimonabant have been well tolerated in other studies. The most common side effects of oral THC are sedation, cognitive impairment, euphoria, poor coordination, tachycardia, and hypotension. Spontaneous withdrawal from cannabis is mild and medically benign. Experience with other drugs suggests that antagonist-elicited cannabis withdrawal may have an earlier onset and greater intensity than spontaneous cannabis withdrawal. There are no clinical benefits to participants. Scientific benefits are greater understanding of cannabis intoxication, tolerance, and withdrawal and of the role of rimonabant in eliciting cannabis withdrawal.
Read the detailed description
Background: Rimonabant, a CB1 receptor antagonist, blocks effects of cannabinoids and, in dependent animals, elicits cannabinoid withdrawal. No studies have examined rimonabantelicited cannabis withdrawal in humans.
Goals: (1) Determine the lowest single dose of oral rimonabant that elicits measurable cannabinoid withdrawal. (2) Characterize cognitive performance, subjective state, physiological condition, and regional brain activation (measured by functional magnetic resonance imaging [fMRI]) during acute and chronic administration of oral delta 9-tetrahydrocannabinol (THC) and during cannabis withdrawal. (3) Characterize the pharmacokinetics of oral THC and metabolites in body fluids and hair and of rimonabant in plasma.
Subject Population: Up to 60 completing cannabis users aged 18-45 (up to 24 in Experiment I, 36 in Experiment II) and 18 completing non-drug-using controls (Experiment II). Enrollment target is 82% Caucasian, 14% African American, 4% other; 9% Hispanic; 35% women.
Experimental Design and Methods: Experiment I: In this within-subject, randomized, double-blind, dose-escalation study, six participants receive 7 days of THC (40-120 mg/day). On Day 8, five participants receive 20 mg rimonabant; one receives placebo. If withdrawal criteria (greater than or equal to 150% or 2.5-fold increase in selected visual-analog scales) are not met in all five participants receiving rimonabant, separate groups of six are similarly treated with 40, 60 or 80 mg rimonabant, if necessary. The PI and MRP will submit all adverse events and relevant cardiovascular and scientific data to the IRB at the completion of each rimonabant dose panel. When the extramural NIDA DSMB is in place, it will review all data collected to date and develop and implement a monitoring plan, including review on completion of each dose cohort. DSMB recommendations will be reviewed by the Sponsor, Clinical Director and IRB before proceeding to the next dose cohort. In addition, if any subject has an intolerable adverse event (ie, an adverse event leading to study discontinuation) or serious adverse event in response to rimonabant on Day 8, the blind for that subject will be broken, and a report sent to the Sponsor, the extramural NIDA DSMB when in place and the IRB for discussion.
Experiment II: In this randomized, placebo-controlled, double-blind study, 36 participants receive 7 days of THC (40-120 mg/day). On Day 8, 18 participants receive rimonabant dose determined in Experiment I to elicit cannabis withdrawal; 18 participants receive placebo rimonabant to evaluate spontaneous cannabis withdrawal. Cognitive, psychological, physiological and hormonal measures are monitored to determine onset, magnitude, and duration of THC intoxication and withdrawal and to correlate with THC and rimonabant pharmacokinetics. Changes in blood oxygen level-dependent (BOLD) signal are determined with five fMRI scans throughout the study. Eighteen non-drug-using controls undergo scanning and cognitive testing at similar intervals.
Risks and Benefits: The proposed doses of THC and rimonabant have been well tolerated in other studies. The most common side effects of oral THC are sedation, cognitive impairment, euphoria, poor coordination, tachycardia, and hypotension. Spontaneous withdrawal from cannabis is mild and medically benign. Experience with other drugs suggests that antagonist-elicited cannabis withdrawal may have an earlier onset and greater intensity than spontaneous cannabis withdrawal. There are no clinical benefits to participants. Scientific benefits are greater understanding of cannabis intoxication, tolerance, and withdrawal and of the role of rimonabant in eliciting cannabis withdrawal.
- Conditions
- Cannabis, Dependence
- Being tested
- THC, Rimonobant, Rimonabant
- Keywords
- Rimonabant, fMRI, Alternative Matrices, Brain Imaging, THC
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THCDrug
RimonobantDrug
RimonabantDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the lowest dose of Rimonabant that elicits cannabis withdrawal.
Secondary outcomes (1)
Cognitive, subjective effects, and brain activation after acute and chronic THC and spontaneous antagonist elicited cannabis withdrawal. Rimonabant and THC pharmacokinetics in various biological matrices.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2009 (estimated)
- Study start16 Apr 2006
- Primary completion11 Jan 2010
- Study completion11 Jan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CannabisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01041170
- Sponsor's protocol ID
- 999906410
- Other IDs
- 06-DA-N410
- Status last verified
- 11 Jan 2010
- First submitted
- 30 Dec 2009
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Menzaghi F, Rassnick S, Heinrichs S, Baldwin H, Pich EM, Weiss F, Koob GF. The role of corticotropin-releasing factor in the anxiogenic effects of ethanol withdrawal. Ann N Y Acad Sci. 1994 Oct 31;739:176-84. doi: 10.1111/j.1749-6632.1994.tb19819.x.
PubMed 7832471Ehrman RN, Robbins SJ, Childress AR, Goehl L, Hole AV, O'Brien CP. Laboratory exposure to cocaine cues does not increase cocaine use by outpatient subjects. J Subst Abuse Treat. 1998 Sep-Oct;15(5):431-5. doi: 10.1016/s0740-5472(97)00290-0.
PubMed 9751000Copersino ML, Boyd SJ, Tashkin DP, Huestis MA, Heishman SJ, Dermand JC, Simmons MS, Gorelick DA. Cannabis withdrawal among non-treatment-seeking adult cannabis users. Am J Addict. 2006 Jan-Feb;15(1):8-14. doi: 10.1080/10550490500418997.
PubMed 16449088Gorelick DA, Goodwin RS, Schwilke E, Schwope DM, Darwin WD, Kelly DL, McMahon RP, Liu F, Ortemann-Renon C, Bonnet D, Huestis MA. Antagonist-elicited cannabis withdrawal in humans. J Clin Psychopharmacol. 2011 Oct;31(5):603-12. doi: 10.1097/JCP.0b013e31822befc1.
PubMed 21869692
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antagonist-Elicited Cannabis Withdrawal
- ClinicalTrials.gov ID
- NCT01041170
- Acronym / sponsor ID
- 999906410
- Conditions
- Cannabis, Dependence
- Keywords
- Rimonabant, fMRI, Alternative Matrices, Brain Imaging, THC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 16 Apr 2006
- Primary completion
- 11 Jan 2010 (actual)
- Study completion
- 11 Jan 2010 (actual)
- First posted
- 31 Dec 2009 (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: Rimonabant, a CB1 receptor antagonist, blocks effects of cannabinoids and, in dependent animals, elicits cannabinoid withdrawal. No studies have examined rimonabantelicited cannabis withdrawal in humans.
Goals: (1) Determine the lowest single dose of oral rimonabant that elicits measurable cannabinoid withdrawal. (2) Characterize cognitive performance, subjective state, physiological condition, and regional brain activation (measured by functional magnetic resonance imaging [fMRI]) during acute and chronic administration of oral delta 9-tetrahydrocannabinol (THC) and during cannabis withdrawal. (3) Characterize the pharmacokinetics of oral THC and metabolites in body fluids and hair and of rimonabant in plasma.
Subject Population: Up to 60 completing cannabis users aged 18-45 (up to 24 in Experiment I, 36 in Experiment II) and 18 completing non-drug-using controls (Experiment II). Enrollment target is 82% Caucasian, 14% African American, 4% other; 9% Hispanic; 35% women.
Experimental Design and Methods: Experiment I: In this within-subject, randomized, double-blind, dose-escalation study, six participants receive 7 days of THC (40-120 mg/day). On Day 8, five participants receive 20 mg rimonabant; one receives placebo. If withdrawal criteria (greater than or equal to 150% or 2.5-fold increase in selected visual-analog scales) are not met in all five participants receiving rimonabant, separate groups of six are similarly treated with 40, 60 or 80 mg rimonabant, if necessary. The PI and MRP will submit all adverse events and relevant cardiovascular and scientific data to the IRB at the completion of each rimonabant dose panel. When the extramural NIDA DSMB is in place, it will review all data collected to date and develop and implement a monitoring plan, including review on completion of each dose cohort. DSMB recommendations will be reviewed by the Sponsor, Clinical Director and IRB before proceeding to the next dose cohort. In addition, if any subject has an intolerable adverse event (ie, an adverse event leading to study discontinuation) or serious adverse event in response to rimonabant on Day 8, the blind for that subject will be broken, and a report sent to the Sponsor, the extramural NIDA DSMB when in place and the IRB for discussion.
Experiment II: In this randomized, placebo-controlled, double-blind study, 36 participants receive 7 days of THC (40-120 mg/day). On Day 8, 18 participants receive rimonabant dose determined in Experiment I to elicit cannabis withdrawal; 18 participants receive placebo rimonabant to evaluate spontaneous cannabis withdrawal. Cognitive, psychological, physiological and hormonal measures are monitored to determine onset, magnitude, and duration of THC intoxication and withdrawal and to correlate with THC and rimonabant pharmacokinetics. Changes in blood oxygen level-dependent (BOLD) signal are determined with five fMRI scans throughout the study. Eighteen non-drug-using controls undergo scanning and cognitive testing at similar intervals.
Risks and Benefits: The proposed doses of THC and rimonabant have been well tolerated in other studies. The most common side effects of oral THC are sedation, cognitive impairment, euphoria, poor coordination, tachycardia, and hypotension. Spontaneous withdrawal from cannabis is mild and medically benign. Experience with other drugs suggests that antagonist-elicited cannabis withdrawal may have an earlier onset and greater intensity than spontaneous cannabis withdrawal. There are no clinical benefits to participants. Scientific benefits are greater understanding of cannabis intoxication, tolerance, and withdrawal and of the role of rimonabant in eliciting cannabis withdrawal.
Detailed description
Background: Rimonabant, a CB1 receptor antagonist, blocks effects of cannabinoids and, in dependent animals, elicits cannabinoid withdrawal. No studies have examined rimonabantelicited cannabis withdrawal in humans.
Goals: (1) Determine the lowest single dose of oral rimonabant that elicits measurable cannabinoid withdrawal. (2) Characterize cognitive performance, subjective state, physiological condition, and regional brain activation (measured by functional magnetic resonance imaging [fMRI]) during acute and chronic administration of oral delta 9-tetrahydrocannabinol (THC) and during cannabis withdrawal. (3) Characterize the pharmacokinetics of oral THC and metabolites in body fluids and hair and of rimonabant in plasma.
Subject Population: Up to 60 completing cannabis users aged 18-45 (up to 24 in Experiment I, 36 in Experiment II) and 18 completing non-drug-using controls (Experiment II). Enrollment target is 82% Caucasian, 14% African American, 4% other; 9% Hispanic; 35% women.
Experimental Design and Methods: Experiment I: In this within-subject, randomized, double-blind, dose-escalation study, six participants receive 7 days of THC (40-120 mg/day). On Day 8, five participants receive 20 mg rimonabant; one receives placebo. If withdrawal criteria (greater than or equal to 150% or 2.5-fold increase in selected visual-analog scales) are not met in all five participants receiving rimonabant, separate groups of six are similarly treated with 40, 60 or 80 mg rimonabant, if necessary. The PI and MRP will submit all adverse events and relevant cardiovascular and scientific data to the IRB at the completion of each rimonabant dose panel. When the extramural NIDA DSMB is in place, it will review all data collected to date and develop and implement a monitoring plan, including review on completion of each dose cohort. DSMB recommendations will be reviewed by the Sponsor, Clinical Director and IRB before proceeding to the next dose cohort. In addition, if any subject has an intolerable adverse event (ie, an adverse event leading to study discontinuation) or serious adverse event in response to rimonabant on Day 8, the blind for that subject will be broken, and a report sent to the Sponsor, the extramural NIDA DSMB when in place and the IRB for discussion.
Experiment II: In this randomized, placebo-controlled, double-blind study, 36 participants receive 7 days of THC (40-120 mg/day). On Day 8, 18 participants receive rimonabant dose determined in Experiment I to elicit cannabis withdrawal; 18 participants receive placebo rimonabant to evaluate spontaneous cannabis withdrawal. Cognitive, psychological, physiological and hormonal measures are monitored to determine onset, magnitude, and duration of THC intoxication and withdrawal and to correlate with THC and rimonabant pharmacokinetics. Changes in blood oxygen level-dependent (BOLD) signal are determined with five fMRI scans throughout the study. Eighteen non-drug-using controls undergo scanning and cognitive testing at similar intervals.
Risks and Benefits: The proposed doses of THC and rimonabant have been well tolerated in other studies. The most common side effects of oral THC are sedation, cognitive impairment, euphoria, poor coordination, tachycardia, and hypotension. Spontaneous withdrawal from cannabis is mild and medically benign. Experience with other drugs suggests that antagonist-elicited cannabis withdrawal may have an earlier onset and greater intensity than spontaneous cannabis withdrawal. There are no clinical benefits to participants. Scientific benefits are greater understanding of cannabis intoxication, tolerance, and withdrawal and of the role of rimonabant in eliciting cannabis withdrawal.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- 18 to 45 years of age;
- Cannabis use of at least one year with a typical pattern of daily use for the three months prior to unit admission;
- A urine sample positive for cannabinoids in the 30 days prior to study enrollment;
- Blood pressure (BP) and heart rate (HR) at or below the following values while sitting after 5 minutes' rest: Systolic BP (SBP) 140 mm Hg, diastolic BP (DBP) 90 mm Hg,
- heart rate (HR) 100 bpm;
Key exclusion criteria (33 listed)
- History or presence of any clinically significant disease state, as detected by history, physical examination, and/or laboratory tests, that might put the subject at increased risk of adverse events or that might interfere with the absorption, distribution, metabolism, or excretion of study drugs;
- Current physical dependence on any substance other than cannabis, nicotine, or caffeine;
- Positive serological tests for syphilis or HIV infection;
- Positive purified protein derivative (PPD) test in the absence of a negative chest Xray;
- Consumption of an investigational drug within 90 days prior to study drug administration;
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 |
|---|---|---|
| THC | Drug | – |
| Rimonobant | Drug | – |
| Rimonabant | Drug | – |
Primary outcome
Determination of the lowest dose of Rimonabant that elicits cannabis withdrawal.
1 secondary outcome
Cognitive, subjective effects, and brain activation after acute and chronic THC and spontaneous antagonist elicited cannabis withdrawal. Rimonabant and THC pharmacokinetics in various biological matrices.
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 2 Jul 2017.
- Background: PubMed 7832471Menzaghi F, Rassnick S, Heinrichs S, Baldwin H, Pich EM, Weiss F, Koob GF. The role of corticotropin-releasing factor in the anxiogenic effects of ethanol withdrawal. Ann N Y Acad Sci. 1994 Oct 31;739:176-84. doi: 10.1111/j.1749-6632.1994.tb19819.x.
- Background: PubMed 9751000Ehrman RN, Robbins SJ, Childress AR, Goehl L, Hole AV, O'Brien CP. Laboratory exposure to cocaine cues does not increase cocaine use by outpatient subjects. J Subst Abuse Treat. 1998 Sep-Oct;15(5):431-5. doi: 10.1016/s0740-5472(97)00290-0.
- Background: PubMed 16449088Copersino ML, Boyd SJ, Tashkin DP, Huestis MA, Heishman SJ, Dermand JC, Simmons MS, Gorelick DA. Cannabis withdrawal among non-treatment-seeking adult cannabis users. Am J Addict. 2006 Jan-Feb;15(1):8-14. doi: 10.1080/10550490500418997.
- Derived from this study: PubMed 21869692Gorelick DA, Goodwin RS, Schwilke E, Schwope DM, Darwin WD, Kelly DL, McMahon RP, Liu F, Ortemann-Renon C, Bonnet D, Huestis MA. Antagonist-elicited cannabis withdrawal in humans. J Clin Psychopharmacol. 2011 Oct;31(5):603-12. doi: 10.1097/JCP.0b013e31822befc1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing THC, Rimonobant and Rimonabant in people with Cannabis and Dependence, run by National Institute on Drug Abuse (NIDA) at 2 sites 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 18 inclusion and 33 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 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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?
Determination of the lowest dose of Rimonabant that elicits cannabis withdrawal.. 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 NCT01041170, which also lists 4 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 2 Jul 2017.