DepressionPhase 2VENNCT00131456
Free Venlafaxine Treatment for Marijuana Addiction and Depression - 1
A Phase 2 study testing Venlafaxine in people with Depression and Marijuana Abuse, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
The purpose of this study is to determine if Venlafaxine Extended Release (Ven-XR) is effective in treating individuals with marijuana addiction and depression. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depression, Marijuana Abuse
- What is being tested?
- Venlafaxine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Dec 2010
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meets criteria for current marijuana addiction and reports marijuana as primary drug of abuse
- Currently meets criteria for major depression or dysthymic disorder and receive a score of greater than or equal to 12 on the Hamilton Depression Inventory
- Clinically depressed for at least 3 months during a period of active marijuana use
- Women of child-bearing age will be included provided that they are not pregnant, based on the results of a blood pregnancy done at the time of screening and agree to use a method of contraception with proven efficacy and not to become pregnant during the study. To confirm this, blood pregnancy tests will be repeated monthly. Women will be provided a full explanation of the potential dangers of pregnancy while on the study. If a woman becomes pregnant, the study medication will be discontinued.
Who cannot join
- Meets criteria for past manic or psychotic disorder, unless substance-related
- History of a seizure disorder
- Individuals with chronic organic mental syndrome
- Any significant risk for suicide based on current assessment and history of attempts
- History of allergic reaction to either Venlafaxine or Ven-XR
- Unstable physical disorders that might make participation hazardous, such as uncontrolled hypertension and tachycardia (SBP>150, DBP >90, or a sitting quietly HR>100), acute hepatitis (patients with chronic mildly elevated transaminase levels (<2x upper limit of normal are acceptable) or unstable diabetes
Show all 10Show fewer
- History of failure to respond to a previous adequate trial of Venlafaxine of at least 300 mg. for at least a 6-week period
- Physical dependence on any other drugs (excluding nicotine) that would require medical detoxification
- Currently being prescribed psychotropic medication by another physician (in the last 3 weeks), except for acute treatment of insomnia.
- Pregnant or breast-feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Marijuana Addiction and Depression: Venlafaxine Treatment
The purpose of this study is to determine if Venlafaxine Extended Release (Ven-XR) is effective in treating individuals with marijuana addiction and depression.
Read the detailed description
Given that depression and marijuana addiction often occur together, medications to treat individuals diagnosed with both conditions may be effective. The purpose of this study is to determine the effectiveness of Ven-XR in treating individuals diagnosed with depression and marijuana addiction.
During this twelve-week, double-blind, placebo-controlled study, study visits will occur twice each week. During study visits, participants will receive either placebo or medication and provide a urine sample for drug screening. Blood tests will be collected each month and women must take pregnancy tests each month. Throughout the study, all participants will receive individualized psychotherapy sessions. At each study visit, participants will be given $5 to cover transportation costs.
- Conditions
- Depression, Marijuana Abuse
- Being tested
- Venlafaxine, Placebo
- Keywords
- cannabis dependence, depression, treatment, venlafaxine
- Medical subject headings
- Depression, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenlafaxineDrug
Also called Effexor
375mg/day
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Venlafaxine | Active comparator | Venlafaxine Receives: Drug: Venlafaxine |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two Consecutive Weeks of Marijuana Abstinence
The primary outcome measure for marijuana use was a dichotomous abstinence response,defined as at least two consecutive urine-confirmed abstinent weeks. Each week during the study, subjects were scored as urine-confirmed abstinent if both self-reported marijuana use for that week was negative, according to the quantitative substance use daily inventory (Timeline FollowBack), and all urines collected for that week were negative for THC. Patients who achieved the two consecutive abstinent weeks were classified as abstinent whether or not they subsequently dropped out of the study. Patients who dropped out of the study without achieving two continuous weeks of abstinence were classified as not abstinent.
Measured: measured daily by self report for 12 weeks of the trial or length of study participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2005 (estimated)
- Study startMar 2004
- Primary completionDec 2010
- Study completionDec 2010
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 DepressionStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Frances R Levin, National Institute on Drug Abuse (NIDA)
- Investigators
- Frances R Levin, M.D., Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00131456
- Sponsor's protocol ID
- #4695
- Other IDs
- R01DA015451
- Acronym
- VEN
- Status last verified
- Apr 2019
- First submitted
- 16 Aug 2005
- Last updated
- 24 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Marijuana Addiction and Depression: Venlafaxine Treatment
- ClinicalTrials.gov ID
- NCT00131456
- Acronym / sponsor ID
- VEN / #4695
- Conditions
- Depression, Marijuana Abuse
- Keywords
- cannabis dependence, depression, treatment, venlafaxine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Mar 2004
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 18 Aug 2005 (estimated)
- Results
- Posted 4 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if Venlafaxine Extended Release (Ven-XR) is effective in treating individuals with marijuana addiction and depression.
Detailed description
Given that depression and marijuana addiction often occur together, medications to treat individuals diagnosed with both conditions may be effective. The purpose of this study is to determine the effectiveness of Ven-XR in treating individuals diagnosed with depression and marijuana addiction.
During this twelve-week, double-blind, placebo-controlled study, study visits will occur twice each week. During study visits, participants will receive either placebo or medication and provide a urine sample for drug screening. Blood tests will be collected each month and women must take pregnancy tests each month. Throughout the study, all participants will receive individualized psychotherapy sessions. At each study visit, participants will be given $5 to cover transportation costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Venlafaxine | Active comparator | Drug: VenlafaxineVenlafaxine |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Meets criteria for current marijuana addiction and reports marijuana as primary drug of abuse
- Currently meets criteria for major depression or dysthymic disorder and receive a score of greater than or equal to 12 on the Hamilton Depression Inventory
- Clinically depressed for at least 3 months during a period of active marijuana use
- Women of child-bearing age will be included provided that they are not pregnant, based on the results of a blood pregnancy done at the time of screening and agree to use a method of contraception with proven efficacy and not to become pregnant during the study. To confirm this, blood pregnancy tests will be repeated monthly. Women will be provided a full explanation of the potential dangers of pregnancy while on the study. If a woman becomes pregnant, the study medication will be discontinued.
Key exclusion criteria (10 listed)
- Meets criteria for past manic or psychotic disorder, unless substance-related
- History of a seizure disorder
- Individuals with chronic organic mental syndrome
- Any significant risk for suicide based on current assessment and history of attempts
- History of allergic reaction to either Venlafaxine or Ven-XR
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 |
|---|---|---|
| VenlafaxineAlso: Effexor375mg/day | Drug | Venlafaxine |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Two Consecutive Weeks of Marijuana Abstinence
Time frame: measured daily by self report for 12 weeks of the trial or length of study participation
The primary outcome measure for marijuana use was a dichotomous abstinence response,defined as at least two consecutive urine-confirmed abstinent weeks. Each week during the study, subjects were scored as urine-confirmed abstinent if both self-reported marijuana use for that week was negative, according to the quantitative substance use daily inventory (Timeline FollowBack), and all urines collected for that week were negative for THC. Patients who achieved the two consecutive abstinent weeks were classified as abstinent whether or not they subsequently dropped out of the study. Patients who dropped out of the study without achieving two continuous weeks of abstinence were classified as not abstinent.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Click here for the Substance Treatment and Research Service websiteLink 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.
Frances R Levin, M.D. principal investigator
New York State Psychiatric Institute
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 Venlafaxine in people with Depression and Marijuana Abuse, run by New York State Psychiatric Institute 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 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 24 Apr 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 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 4 Jun 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?
Two Consecutive Weeks of Marijuana Abstinence (time frame: measured daily by self report for 12 weeks of the trial or length of study participation). 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 24 Apr 2019.