CannabisEarly Phase 1NCT00842985
Dronabinol Interactions With Cognitive Enhancing Drug in Humans
A Early Phase 1 study testing drug condition in people with Cannabis and Marijuana Abuse, run by Yale University at 1 site in United States.
Trial summary
Marijuana use is a major problem among veterans and non-veterans. A patient's use of marijuana while engaged in psychotherapy treatment may affect their memory and, therefore, limit their ability to benefit from treatment. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Cannabis, Marijuana Abuse
- What is being tested?
- drug condition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Oct 2009
- Phase
- Early Phase 1
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Males and females between 18 and 55 years old will be eligible for this study.
- Marijuana used at least once in last 2 months and at least 10 times in lifetime.
- Subjects do not meet DSM-IV criteria for marijuana abuse or dependence.
- Subjects are NOT seeking treatment for substance abuse or dependence.
- Females must not be pregnant as determined by pregnancy screening, nor breast feeding, and must be using acceptable birth control methods other than oral contraceptive pills (OCP). Modafinil may cause OCP to be ineffective. Acceptable forms of birth control are condoms, diaphragms, and IUDs.
- No alcohol or drugs 24 hours prior to testing session.
- Subjects must agree to not drive to or from session.
Who cannot join
- • History of heart disease, left ventricular hypertrophy, ischemic ECG changes, chest pain, arrhythmia, hypertension.
- History of severe renal or hepatic diseases.
- History of psychosis, schizophrenia or bipolar type I disorder.
- History of seizure disorder.
- Current diagnosis of alcohol and other drug dependence (other than nicotine).
- A positive urine toxicology result for cocaine or opiates at intake.
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- Current use of over-the-counter or prescription psychoactive drugs (antidepressant, anxiolytics, antipsychotics, mood stabilizers, psychostimulants).
- Liver function tests (ALT or AST) greater than 3 times normal.
- Known allergy to modafinil or dronabinol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Veterans Affairs Hospital
West Haven, Connecticut, 06516
About this study
Official title: Dronabinol Interactions in Humans
Marijuana use is a major problem among veterans and non-veterans. A patient's use of marijuana while engaged in psychotherapy treatment may affect their memory and, therefore, limit their ability to benefit from treatment. This study is designed to test a new pharmacotherapy, modafinil, which has the potential to improve memory functioning in marijuana using individuals.
We hypothesize that modafinil treatment will decrease ratings of drug liking and improve cognitive measures, especially episodic memory.
Read the detailed description
The impairment of episodic memory in marijuana abusers has important treatment implications. Since many treatments, including cognitive-behavioral therapy, strongly utilize episodic memory, marijuana use during treatment may lead to diminished treatment outcomes. In addition, lessened response inhibition may lead to elevated rates of drug relapse while in treatment. Consequently, a treatment which will improve episodic memory and response inhibition may lead to improved treatment outcomes in marijuana users. One such treatment is modafinil.This study will be a 4 session within-subjects, double-blind, crossover study evaluating the impact of modafinil (400 mg/day) on the cognitive, subjective, and physiological effects of marijuana. Across 4 sessions, subjects will be randomly assigned to receive either oral placebo, modafinil (400mg), dronabinol (15mg), or dronabinol and modafinil. Outcome measures will include physiological, cognitive, and subjective drug effects.
Currently this study complete and has been published.
- Conditions
- Cannabis, Marijuana Abuse
- Being tested
- drug condition
- Keywords
- Cannabis Abuse, Cannabis Dependence, Cannabis-Related Disorder, Marijuana Dependence, Marihuana Abuse
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drug conditionDrug
Also called Marinol, Provigil,
Dronabinol (15mg) or Modafinil (400mg) or Dronabinol + Modafanil or placebo
| Study group | Role | What they receive |
|---|---|---|
| drug condition | Other | Participants received each drug condition in sequential order across 4 test days. Not all participants received the interventions in the same order. Receives: Drug: drug condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
CANTAB:CAmbridge Neuropsychological Test Automated Battery RVIP: Rapid Visual Information Processing
CANTAB RVIP is one component of this computerized battery and is a measure of sustained attention with a working memory component.
This study used two subscales of the RVIP.
- RVP A' ( Target sensitivity, a measure of the ability to detect sequences.) The range is from 0-1; bad to good.
- RVP B'' ( Response bias, which is a measure of the tendency to respond regardless of whether a target is present.
The range is from -1 to +1 ; bad to good
The numbers represent probabilities as units on a scale.
Measured: Once for each test session (4 total).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2009 (estimated)
- Study startSep 2008
- Primary completionOct 2009
- Study completionOct 2009
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CannabisStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- VA Office of Research and Development, National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Mehmet Sofuoglu, Yale University
- Investigators
- Mehmet Sofuoglu, M.D,Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00842985
- Sponsor's protocol ID
- 0702002357
- Other IDs
- MIRECC 00000000, P50DA009241
- Status last verified
- Apr 2017
- First submitted
- 11 Feb 2009
- Last updated
- 30 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Sugarman DE, Poling J, Sofuoglu M. The safety of modafinil in combination with oral ∆9-tetrahydrocannabinol in humans. Pharmacol Biochem Behav. 2011 Mar;98(1):94-100. doi: 10.1016/j.pbb.2010.12.013. Epub 2010 Dec 21.
PubMed 21176784Bosnjak Kuharic D, Markovic D, Brkovic T, Jeric Kegalj M, Rubic Z, Vuica Vukasovic A, Jeroncic A, Puljak L. Cannabinoids for the treatment of dementia. Cochrane Database Syst Rev. 2021 Sep 17;9(9):CD012820. doi: 10.1002/14651858.CD012820.pub2.
PubMed 34532852
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dronabinol Interactions in Humans
- ClinicalTrials.gov ID
- NCT00842985
- Acronym / sponsor ID
- 0702002357
- Conditions
- Cannabis, Marijuana Abuse
- Keywords
- Cannabis Abuse, Cannabis Dependence, Cannabis-Related Disorder, Marijuana Dependence, Marihuana Abuse
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- VA Office of Research and Development, National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 12 Feb 2009 (estimated)
- Results
- Posted 17 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Marijuana use is a major problem among veterans and non-veterans. A patient's use of marijuana while engaged in psychotherapy treatment may affect their memory and, therefore, limit their ability to benefit from treatment. This study is designed to test a new pharmacotherapy, modafinil, which has the potential to improve memory functioning in marijuana using individuals.
We hypothesize that modafinil treatment will decrease ratings of drug liking and improve cognitive measures, especially episodic memory.
Detailed description
The impairment of episodic memory in marijuana abusers has important treatment implications. Since many treatments, including cognitive-behavioral therapy, strongly utilize episodic memory, marijuana use during treatment may lead to diminished treatment outcomes. In addition, lessened response inhibition may lead to elevated rates of drug relapse while in treatment. Consequently, a treatment which will improve episodic memory and response inhibition may lead to improved treatment outcomes in marijuana users. One such treatment is modafinil.This study will be a 4 session within-subjects, double-blind, crossover study evaluating the impact of modafinil (400 mg/day) on the cognitive, subjective, and physiological effects of marijuana. Across 4 sessions, subjects will be randomly assigned to receive either oral placebo, modafinil (400mg), dronabinol (15mg), or dronabinol and modafinil. Outcome measures will include physiological, cognitive, and subjective drug effects.
Currently this study complete and has been published.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| drug condition | Other | Drug: drug conditionParticipants received each drug condition in sequential order across 4 test days. Not all participants received the interventions in the same order. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- • Males and females between 18 and 55 years old will be eligible for this study.
Key exclusion criteria (9 listed)
- • History of heart disease, left ventricular hypertrophy, ischemic ECG changes, chest pain, arrhythmia, hypertension.
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 |
|---|---|---|
| drug conditionAlso: Marinol, Provigil,Dronabinol (15mg) or Modafinil (400mg) or Dronabinol + Modafanil or placebo | Drug | drug condition |
Primary outcome
CANTAB:CAmbridge Neuropsychological Test Automated Battery RVIP: Rapid Visual Information Processing
Time frame: Once for each test session (4 total).
CANTAB RVIP is one component of this computerized battery and is a measure of sustained attention with a working memory component. This study used two subscales of the RVIP. 1. RVP A' ( Target sensitivity, a measure of the ability to detect sequences.) The range is from 0-1; bad to good. 2. RVP B'' ( Response bias, which is a measure of the tendency to respond regardless of whether a target is present. The range is from -1 to +1 ; bad to good The numbers represent probabilities as units on a scale.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21176784Sugarman DE, Poling J, Sofuoglu M. The safety of modafinil in combination with oral ∆9-tetrahydrocannabinol in humans. Pharmacol Biochem Behav. 2011 Mar;98(1):94-100. doi: 10.1016/j.pbb.2010.12.013. Epub 2010 Dec 21.
- Derived from this study: PubMed 34532852Bosnjak Kuharic D, Markovic D, Brkovic T, Jeric Kegalj M, Rubic Z, Vuica Vukasovic A, Jeroncic A, Puljak L. Cannabinoids for the treatment of dementia. Cochrane Database Syst Rev. 2021 Sep 17;9(9):CD012820. doi: 10.1002/14651858.CD012820.pub2.
- Individual participant dataSharing planned: No
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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.
Mehmet Sofuoglu, M.D,Ph.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing drug condition in people with Cannabis and Marijuana Abuse, run by Yale University 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 7 inclusion and 9 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 30 May 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 17 Dec 2012). 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?
CANTAB:CAmbridge Neuropsychological Test Automated Battery RVIP: Rapid Visual Information Processing (time frame: Once for each test session (4 total).). 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 NCT00842985, which also lists 2 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 30 May 2017.