Marijuana AbusePhase 2NCT00142870
Effectiveness of Bupropion in Treating Marijuana Dependent Individuals
A Phase 2 study testing Bupropion in people with Marijuana Abuse and Substance-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
A definable and significant withdrawal syndrome occurs upon cessation of chronic, heavy marijuana use. Bupropion (Zyban) is a medication currently used to treat withdrawal symptoms associated with tobacco use. The purpose of this study is to determine if bupropion will help individuals stop using marijuana. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Marijuana Abuse, Substance-Related Disorders
- What is being tested?
- Bupropion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to May 2006
- Phase
- Phase 2
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Current marijuana use and dependence
- Marijuana use of at least 5 times in the past 7 days or more than 25 times per month for the 3 years prior to enrollment
- Unsuccessful in a previous attempt to quit marijuana
Who cannot join
- Axis I disorder
- Any drug abuse or dependence other than marijuana
- Currently taking antipsychotic or antidepressant medication
- Heavy alcohol drinker (more than 20 drinks per week)
- Current nicotine dependence
- History of a seizure disorder
Show all 10Show fewer
- Current or prior eating disorder (e.g., bulimia or anorexia nervosa)
- Heavy caffeine use (more than 300 mg per day)
- Life threatening or unstable medical illness
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
McLean Hospital, Dept. of Psychiatry
Belmont, Massachusetts, 02478 9106
About this study
Official title: Effects of Bupropion on Marijuana Withdrawal Symptoms
A definable and significant withdrawal syndrome occurs upon cessation of chronic, heavy marijuana use. Bupropion (Zyban) is a medication currently used to treat withdrawal symptoms associated with tobacco use. The purpose of this study is to determine if bupropion will help individuals stop using marijuana.
Read the detailed description
A definable and significant withdrawal syndrome occurs upon cessation of chronic, heavy marijuana use. This syndrome includes alterations in mood, sleep disturbances, and cognitive performance. Many of nicotine's withdrawal symptoms are similar to those observed with marijuana withdrawal. Bupropion has been shown to be effective in treating nicotine addiction.The purpose of this study is to determine if bupropion is effective in treating marijuana dependent individuals. Specifically, this study will determine if bupropion alleviates withdrawal symptoms associated with marijuana abuse.
Participants in this 21-day, double-blind study will be randomly assigned to receive either bupropion or placebo. Treatment with bupropion will occur for one week before stopping marijuana use (quit day). Bupropion will be administered at 150 mg per day for 3 days, followed by 300 mg per day for the remainder of the study. Quit day will occur on Day 8, at which time participants will be required to remain abstinent from marijuana for the duration of the study. Participants will provide daily urine specimens. Changes in vigilance, memory, reaction time, and psychomotor performance as well as withdrawal symptoms will be evaluated.
- Conditions
- Marijuana Abuse, Substance-Related Disorders
- Being tested
- Bupropion
- Keywords
- marijuana, treatment
- Medical subject headings
- Marijuana Abuse, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupropionDrug
Also called Zyban
150 mg, twice a day
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Not described Receives: Drug: Bupropion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Withdrawal severity
Measured: on a daily basis for 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startMar 2005
- Primary completionMay 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Marijuana AbuseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- David M Penetar, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00142870
- Sponsor's protocol ID
- NIDA-17275-1
- Other IDs
- R03-17275-1, DPMC
- Status last verified
- Oct 2016
- First submitted
- 1 Sep 2005
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Penetar DM, Looby AR, Ryan ET, Maywalt MA, Lukas SE. Bupropion reduces some of the symptoms of marihuana withdrawal in chronic marihuana users: a pilot study. Subst Abuse. 2012;6:63-71. doi: 10.4137/SART.S9706. Epub 2012 Jun 25.
PubMed 22879754
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Bupropion on Marijuana Withdrawal Symptoms
- ClinicalTrials.gov ID
- NCT00142870
- Acronym / sponsor ID
- NIDA-17275-1
- Conditions
- Marijuana Abuse, Substance-Related Disorders
- Keywords
- marijuana, treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Mar 2005
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 2 Sep 2005 (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.
A definable and significant withdrawal syndrome occurs upon cessation of chronic, heavy marijuana use. Bupropion (Zyban) is a medication currently used to treat withdrawal symptoms associated with tobacco use. The purpose of this study is to determine if bupropion will help individuals stop using marijuana.
Detailed description
A definable and significant withdrawal syndrome occurs upon cessation of chronic, heavy marijuana use. This syndrome includes alterations in mood, sleep disturbances, and cognitive performance. Many of nicotine's withdrawal symptoms are similar to those observed with marijuana withdrawal. Bupropion has been shown to be effective in treating nicotine addiction.The purpose of this study is to determine if bupropion is effective in treating marijuana dependent individuals. Specifically, this study will determine if bupropion alleviates withdrawal symptoms associated with marijuana abuse.
Participants in this 21-day, double-blind study will be randomly assigned to receive either bupropion or placebo. Treatment with bupropion will occur for one week before stopping marijuana use (quit day). Bupropion will be administered at 150 mg per day for 3 days, followed by 300 mg per day for the remainder of the study. Quit day will occur on Day 8, at which time participants will be required to remain abstinent from marijuana for the duration of the study. Participants will provide daily urine specimens. Changes in vigilance, memory, reaction time, and psychomotor performance as well as withdrawal symptoms will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: Bupropion |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Current marijuana use and dependence
- Marijuana use of at least 5 times in the past 7 days or more than 25 times per month for the 3 years prior to enrollment
- Unsuccessful in a previous attempt to quit marijuana
Key exclusion criteria (10 listed)
- Axis I disorder
- Any drug abuse or dependence other than marijuana
- Currently taking antipsychotic or antidepressant medication
- Heavy alcohol drinker (more than 20 drinks per week)
- Current nicotine dependence
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 |
|---|---|---|
| BupropionAlso: Zyban150 mg, twice a day | Drug | A |
Primary outcome
Withdrawal severity
Time frame: on a daily basis for 14 days
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 12 Jan 2017.
- Results publication: PubMed 22879754Penetar DM, Looby AR, Ryan ET, Maywalt MA, Lukas SE. Bupropion reduces some of the symptoms of marihuana withdrawal in chronic marihuana users: a pilot study. Subst Abuse. 2012;6:63-71. doi: 10.4137/SART.S9706. Epub 2012 Jun 25.
- Related InfoLink provided by the sponsor.
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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.
David M Penetar principal investigator
Mclean Hospital
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 Bupropion in people with Marijuana Abuse and Substance-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 3 inclusion and 10 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 12 Jan 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. 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?
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?
Withdrawal severity (time frame: on a daily basis for 14 days). 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 NCT00142870, which also lists 1 linked publication.
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 12 Jan 2017.